Drug Recall Class
Class 1 Recall : Reasonable probability that using the drug will cause serious adverse health consequences or death.
Class 2 Recall: Using the drug may cause temporary or medically reversible adverse health consequences, the probability of serious adverse health consequences is remote.
Class 3 Recall: Using the drug is not likely to cause adverse health consequences.
Drug Recall List Last Updated: January 2022
Drug Recall Details Contact Date Drug Recall Class* Lexette (halobetasol propionate) CGMP Deviation If you have questions January Class 05186260450 about this recall, Mayne Pharma Inc, 844 825 8500 2022 II Clobazam 07778905804 Failed Stability Specifications If you have questions about this recall, January 2022 Class II Ingenus Pharmaceuticals LLC, 877-530-1633. Clobetasol Propionate CGMP Deviations If you have questions January Class 05074230450 05074230401 about this recall, Ingenus Pharmaceuticals LLC, 1-407-354-5740 2022 II Brinzolamide Defective Container If you have questions January Class 00591212779 00591212712 about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 2022 II
8.4% Sodium Bicarbonate Lack of Assurance of Sterility If you have questions January Class 05175450011 about this recall, Exela 2022 II Pharma Sciences LLC, 1- 888-451-4321 Metformin 70518292000 CGMP Deviations If you have questions about this recall, January 2022 Class II RemedyRepack Inc., 1- 866-845-3791 Norepinephrine Bitartrate 00703115303 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals January 2022 Class II USA, 1-800-545-8800 MethylPREDNISolone Acetate 01671409001 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals January 2022 Class II USA, 1-800-545-8800 Carbamazepine 01366826801 Failed Dissolution Specifications If you have questions about this recall, January 2022 Class II Torrent Pharma Inc, 1- 888-280-2040. Clobetasol Propionate 05167212593 Microbial Contamination of Non-Sterile Products If you have questions about this recall, Taro Pharmaceuticals U.S.A., Inc.,1-800-544-1449 ext January 2022 Class I 6066.
Pregabalin 04733568788 Failed Tablet/Capsule Specifications If you have questions about this recall, SUN PHARMACEUTICAL INDUSTRIES INC, 1-800- 818-4555 January 2022 Class II Lidocaine Hydrochloride 06373999764 Superpotent Drug If you have questions about this recall, Teligent Pharma, 1-856-697-1441 January 2022 Class II Lidocaine Hydrochloride 06373999764 Superpotent Drug If you have questions about this recall, Teligent Pharma, 1-856-697-1441 January 2022 Class I Betamethasone Dipropionate 05256502329 Failed Stability Specifications If you have questions about this recall, Teligent Pharma, 1-856-697-1441 January 2022 Class II Penicillin V Potassium 00093412573 00093412574 Subpotent If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 December 2021 Class II Fexofenadine Hydrochloride 00904697940 Failed Impurities/Degradation Specifications If you have questions about this recall, The Harvard Drug Group, 1- 800-875-0123. December 2021 Class II
Clindamycin and Benzoyl Peroxide Gel 00781726368 Superpotent Drug If you have questions about this recall, TOLMAR, Inc., 1-970-212- 4500 December 2021 Class II Lidocaine Hydrochloride 05256500950 Superpotent Drug If you have questions about this recall, Teligent Pharma, 1-856-697-1441 December 2021 Class I Lidocaine Hydrochloride 06373999764 05256500950 CGMP Deviations If you have questions about this recall, Teligent Pharma, 1-856-697-1441 December 2021 Class II Cefixime 70518274902 Failed Impurities/Degradation Specifications If you have questions about this recall, RemedyRepack Inc., 1- 866-845-3791 December 2021 Class II Diclofenac Sodium 68788770701 Defective container If you have questions about this recall, Preferred Pharmaceuticals, Inc., 1- 714-777-3729 December 2021 Class II Hydrocodone Bitartrate and Acetaminophen 03172299701 Product Mix-up If you have questions about this recall, Ascent Pharmaceuticals, Inc., 1-631-851-0550 December 2021 Class II
Cefixime 06787758450 Failed impurities/degradation specifications If you have questions about this recall, Ascend Laboratories, LLC, 1-201-476-1977 December 2021 Class II Ascorbic Acid Lack of Assurance of Sterility If you have questions about this recall, ASP Cares, 1-210-615-7400 December 2021 Class II Diclofenac Sodium 05266500205 05266502505 Defective Container If you have questions about this recall, Teligent Pharma, 1-856-697-1441 December 2021 Class II Flocinolone Acetonide 06516270486 06516270386 Subpotent Drug If you have questions about this recall, Amneal Pharmaceuticals., 1-833- 582-0812. December 2021 Class II Cefixime 06787758450 Failed Impurities/Degradation Specifications If you have questions about this recall, Ascend Laboratories LLC, 1-201-476-1977 November 2021 Class II Tadalafil 01671407501 01671407701 Incorrect Product Formulation If you have questions about this recall, SUN PHARMACEUTICAL INDUSTRIES INC, 1-800- 818-4555 November 2021 Class II
Ezetimibe and Simvastatin 05140719305 Failed Excipient Specification If you have questions about this recall, Dr. Reddy’s Laboratories, Inc., 1-888-375-3784 November 2021 Class II Ezetimibe and Simvastatin 05140719290 05140719205 cGMP Deviations If you have questions about this recall, Dr. Reddy’s Laboratories, Inc., 1-888-375-3784 November 2021 Class II Methocarbamol 07133517952 07133517954 07133517957 Labeling: Label Error on Declared Strength If you have questions about this recall, 1-877- 885-0882. November 2021 Class I Irbesartan and Hydrochlorothiazide 06818041306 06818041309 06818041406 06818041409 CGMP Deviations If you have questions about this recall, Lupin Pharmaceuticals Inc.1- 410-576-2000 ext 3 November 2021 Class II Irbesartan 06818041006 06818041009 06818041106 06818041109 06818041206 06818041209 CGMP Deviations If you have questions about this recall, Lupin Pharmaceuticals Inc.1- 410-576-2000 ext 3 November 2021 Class II
Ezetimibe and Simvastatin 04359874290 04359874210 04359874430 04359874490 04359874530 04359874590 04359874505 04359874330 04359874390 04359874305 Failed Excipient Specifications If you have questions about this recall, Dr. Reddy’s Laboratories, Inc., 1-888-375-3784 November 2021 Class II Rocuronium Bromide 66794022841 Labeling: Label Lacks Warning or Rx Legend If you have questions about this recall, Piramal Critical Care, Inc. 1-800-414-1901 October 2021 Class II Imipramine Pamoate Out of specification result observed in a dissolution test If you have questions about this recall, Lupin Pharmaceuticals Inc.1- 410-576-2000 ext 3 October 2021 Class II Omeprazole Delayed-Release 07000002321 CGMP Deviations If you have questions about this recall, Dr. Reddy’s Laboratories, Inc. 1-888-375-3784 October 2021 Class II
AirDuo Digihaler 232/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) 05931013606 Subpotent drug If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 October 2021 Class II AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) 05931012906 Subpotent drug If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 October 2021 Class II AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) 05931011106 Subpotent drug If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 October 2021 Class II AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) 05931053008 Subpotent drug If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 October 2021 Class II AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) 05931052008 Subpotent drug If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 October 2021 Class II
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) 05931052008 Subpotent drug If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 October 2021 Class II GlipiZIDE Extended-Release 06808429521 06808429511 Failed Dissolution Specifications: results were above specification. If you have questions about this recall, American Health Packaging, 1-614-492-8177 October 2021 Class II Glucagon Emergency Kit 00002803101 Subpotent Drug If you have questions about this recall, Eli Lilly & Company, 1-800-545-5979 October 2021 Class I Betaxolol Ophthalmic 01747870510 01747870511 Microbial Contamination of Sterile Products If you have questions about this recall, Akorn, Inc., 1-855-526- 4827 October 2021 Class II Artesunate 07360700101 07360700111 07360700101 Lack of Assurance of Sterility If you have questions about this recall, AMIVAS (US), LLC, 1-855-526-4827 October 2021 Class II
07360700102 07360700110 Meclizine HCl Tablets, 25 mg 01657175201 Labeling: Incorrect Instructions If you have questions about this recall, RISING PHARMACEUTICALS, 1-866-562-4597 October 2021 Class II Firvanq (vancomycin hydrochloride for oral solution) 06562820605 Product Mix-up If you have questions about this recall, Azurity Pharmaceuticals, Inc., 1-800-461-7449 October 2021 Class I Morphine Sulfate 06332345201 Defective container If you have questions about this recall, Fresenius Kabi USA, 1- 800-551-7176. October 2021 Class II Valproic Acid 06068726256 06068726242 CGMP Deviations If you have questions about this recall, American Health Packaging, 1-800- 707-4621. October 2021 Class II Lyrica CR (pregabalin) 00071102901 Failed Dissolution Specifications If you have questions about this recall, Pfizer Inc.,1-800-438-1985. October 2021 Class II
Zonisamide 61919077530 CGMP deviations If you have questions about this recall, Direct Rx, 1-678-619-5510 September 2021 Class II Metoprolol Tartrate 06586206499 Presence of Foreign Substance If you have questions about this recall, Aurobindo Pharma USA Inc., 1-866-850-2876 September 2021 Class II Entacapone 00904682204 Failed Dissolution Specifications If you have questions about this recall, The Harvard Drug Group, 1- 800-875-0123. September 2021 Class II Valproic Acid 06043262116 CGMP Deviations If you have questions about this recall, Morton Grove Pharmaceuticals, Inc., 1- 888-721-7115 September 2021 Class II Promethazine With Codeine 06043260616 CGMP Deviations If you have questions about this recall, Morton Grove Pharmaceuticals, Inc., 1- 888-721-7115 September 2021 Class II Promethazine Syrup 06043260816 CGMP Deviations If you have questions about this recall, Morton Grove Pharmaceuticals, Inc., 1- 888-721-7115 September 2021 Class II
Arformoterol Tartrate 06846283365 06846283335 Lack of Assurance of Sterility If you have questions about this recall, Glenmark Pharmaceuticals Inc, 1-888-721-7115 September 2021 Class II Zonisamide 06846212901 06846213001 06846213005 CGMP Deviations If you have questions about this recall, Glenmark Pharmaceuticals Inc, 1-888-721-7115 September 2021 Class II Chlorzoxazone 06846272401 06846272501 CGMP Deviations If you have questions about this recall, Glenmark Pharmaceuticals Inc, 1-888-721-7115 September 2021 Class II Naproxen Sodium 06846217801 06846217901 06846217905 CGMP Deviations If you have questions about this recall, Glenmark Pharmaceuticals Inc, 1-888-721-7115 September 2021 Class II Fulvestrant 06846231732 Lack of Assurance of Sterility If you have questions about this recall, Glenmark Pharmaceuticals Inc, 1-888-721-7115 September 2021 Class II
Carbamazepine 00904617261 Failed Dissolution Specifications If you have questions about this recall, The Harvard Drug Group, 1- 800-875-0123. September 2021 Class II Betadine Solution Swabstick 06761815301 06761815303 Subpotent Drug If you have questions about this recall, AVRIO HEALTH L.P, 1- 888-726-7535 September 2021 Class II Chantix (varenicline) 00069047103 00069046856 00069046956 00069046903 CGMP Deviations If you have questions about this recall, Pfizer Inc.,1-800-438-1985. September 2021 Class II Oxycodone Hydrochloride 04285800201 Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle If you have questions about this recall, Akorn, Inc, Rhodes Pharmaceuticals, L.P., 1-401-262-9400, Prompt 2 September 2021 Class II Betamethasone Dipropionate 06174848030 Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product. If you have questions about this recall, Akorn, Inc, 1-800-932-5676, Prompt 2 September 2021 Class II Naproxen Sodium 06220776236 CGMP Deviations If you have questions about this recall, Granules USA, Inc., 1877-770-3183 September 2021 II
Clopidogrel 03334206015 Presence of foreign matter If you have questions about this recall, Macleods Pharma Usa Inc, 1-888-943-3210 September 2021 II Cyclobenzaprine Hydrochloride 00591333001 07019901401 05723726601 CGMP Deviations If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 September 2021 II FLUDARABINE PHOSPHATE FOR INJECTION 02420123701 Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing. If you have questions about this recall, Custopharm, Inc., 1760- 683-0901 September 2021 II Erythromycin Topical Solution 05256502759 Defective container: possibility for lack of seal integrity. If you have questions about this recall, Teligent Pharma, 1-856-697-1441 September 2021 II Atovaquone Oral Suspension 01070222321 Temperature abuse: the firm received customer complaints of unusual grittiness in the product. If you have questions about this recall, KVK-Tech, Inc., 1-215- 579-1842 September 2020 II Carvedilol 06838209505 70518182601 Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle If you have questions about this recall, RemedyRepack Inc., 1- 866-845-3791 September 2021 II
Adenosine 01671418001 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 August 2021 II Leucovorin Calcium 00703514001 00703514591 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 August 2021 II Octreotide Acetate 00703331101 00703330101 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 August 2021 II Methylprednisolone Acetate 00703005101 00703006301 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA 1-800-545-8800 August 2021 II Alprostadil 00703150101 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA 1-800-545-8800 August 2021 II Metoclopramide 00703450201 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 August 2021 II Adenosine Injection 00703877601 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 August 2021 II
Norepinephrine Bitartrate 00703115301 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 August 2021 II Epoprostenol Sodium 00703199501 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 August 2021 II Leucovorin Calcium 00703514501 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 August 2021 II Octreotide Acetate 00703333301 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA 1-800-545-8800 August 2021 II Vecuronium Bromide 00703291401 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA 1-800-545-8800 August 2021 II Idarubicin Hydrochloride 00703415611 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 August 2021 II Amikacin Sulfate 00703904001 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 August 2021 II
Haloperidol Decanoate 00703713101 00703713301 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 August 2021 II Methylprednisolone Acetate 00703003101 00703004301 00703004501 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 August 2021 II DAUNOrubicin Hydrochloride 00703523313 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 August 2021 II GaviLyteTM 04338606019 Failed Stability Specification; Out of specification for Osmolarity If you have questions about this recall, Lupin Pharmaceuticals Inc.1- 410-576-2000 ext 3 August 2021 II Combipatch 06896805148 06896805258 Failed Stability Specifications; out of specification for shear. If you have questions about this recall, Noven Pharmaceuticals Inc, 1-305-253-5099 August 2021 II Tizanidine HCl 05511118015 Failed Tablet/Capsule Specification: Some tablets are shaved If you have questions about this recall, Dr. Reddy’s Laboratories, Inc., 1-888-375-3784 August 2021 II
Triamcinolone Acetonide 05256501480 Correct Labeled Product Mispack If you have questions about this recall, Teligent Pharma, 1-856-697-1441 August 2021 II Econazole Nitrate 05256501480 Correct Labeled Product Mispack If you have questions about this recall, Teligent Pharma, 1-856-697-1441 August 2021 II Ethosuximide 00121067016 Voluntary: Firm initiated If you have questions about this recall, PAI Holdings, LLC. dba Pharmaceutical Associates Inc1-864-277- 7282 ext 0 August 2021 II Cimetidine Hydrochloride 00121064908 Voluntary: Firm initiated If you have questions about this recall, PAI Holdings, LLC. dba Pharmaceutical Associates Inc1-864-277- 7282 ext 0 August 2021 II Nystatin Oral 00121086816 00121086802 Voluntary: Firm initiated If you have questions about this recall, PAI Holdings, LLC. dba Pharmaceutical Associates Inc1-864-277- 7282 ext 0 August 2021 II
Venlafaxine 01671465701 Voluntary: Firm initiated August 2021 II Sulfamethoxazole and Trimethoprim 06586242005 Voluntary: Firm initiated If you have questions about this recall, Aurobindo Pharma USA Inc., 1-866-850-2876 August 2021 II Zyprexa Intramuscular, Olanzapine 00002759701 Voluntary: Firm initiated If you have questions about this recall, Eli Lilly & Company. 1-317-276- 2000 August 2021 II Chantix 00069046856 00069047103 00069046956 CGMP Deviations If you have questions about this recall, Pfizer Inc.,1-800-438-1985. August 2021 II Estriol 04614430001 cGMP Deviations If you have questions about this recall, API Solutions Inc., 1-855-878-1489 August 2021 II NIFEdipine EXTENDED- RELEASE 00904708061 00904708006 Failed Dissolution Specification If you have questions about this recall, Ingenus Pharmaceutical. 1-877- 748-1970 July 2021 II
Solifenacin Succinate 06909726102 CGMP Deviations If you have questions about this recall, CIPLA, 1-866-604-3268. July 2021 II Xylocaine-MPF with Epinephrine 06332348737 06332348707 Low out of specification results for epinephrine assay If you have questions about this recall, Genentech Inc, 1-888- 835-2555. July 2021 II Xolair (omalizumab) 05024221501 Failed Stability Specifications If you have questions about this recall, Fresenius Kabi USA, 1- 800-551-7176. July 2021 II Buprenorphine and Naloxone Sublingual Film 04778135503 Subpotent drug If you have questions about this recall, Alvogen, Inc. 1-866-770-3024 July 2021 II Topotecan Injection 00703471471 Presence of Particulate Matter If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 July 2021 I Metformin Hydrochloride Extended-Release 07257803601 CGMP Deviations If you have questions about this recall, VIONA PHARMACEUTICALS INC 1-888-304-5022 June 2021 Class II DermOtic Oil (fluocinolone acetonide oil) 68791-103-20 Presence of Foreign Substance If you have questions about this recall, Hill Dermaceuticals, Inc.,1-407-323-1998 June 2021 Class II
Diflorasone Diacetate Ointment 05256506315 05256506330 Presence of Foreign Substance If you have questions about this recall, Teligent Pharma, 1-856-697-1441 June 2021 Class II BusPIRone Hydrochloride 06958409310 Presence of Foreign Tablets/Capsules If you have questions about this recall, Oxford Pharmaceuticals, LLC, 1- 205-434-9649 June 2021 Class II Micardis 0597004137 Subpotent Drug If you have questions about this recall, Boehringer Ingelheim Pharmaceuticals, Inc., 1- 908-927-1400 June 2021 Class II ChloraPrep With Tint 2% w/v chlorhexidine gluconate 005436540011 Microbial Contamination of Non- Sterile Product If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800. May 2021 Class I ChloraPrep One-Step 2% w/v chlorhexidine gluconate 005436540001 Microbial Contamination of Non- Sterile Product If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800. May 2021 Class I BD ChloraPrep Hi-Lite Orange 2 05436540033 Non-sterility If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800. May 2021 Class I
BD ChloraPrep Clear 05436540032 Non-sterility If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800. May 2021 Class I Estradiol Transdermal System 06896834378 Defective Delivery System If you have questions about this recall, Noven Pharmaceuticals Inc, 1-305-253-5099 April 2021 Class II Minivelle 06896866758 Defective Delivery System If you have questions about this recall, Noven Pharmaceuticals Inc, 1-305-253-5099 April 2021 Class II Itraconazole 05974628230 Failed Dissolution Specifications If you have questions about this recall, Jubilant Cadista Pharmaceuticals, Inc., 1- 410- 860-2836 April 2021 Class II Riomet (metformin hydrochloride oral solution) 01063120602 Microbial Contamination of Non- Sterile Product If you have questions about this recall, SUN PHARMACEUTICAL INDUSTRIES INC, 1-800- 818-4555 April 2021 Class II Cefprozil 06818040201 06818040202 06818040203 Superpotent Drug If you have questions about this recall, Lupin Pharmaceuticals Inc., 1-866-587-4617 April 2021 Class II
Guanfacine Extended-Release 06050539281 36050539281 Cross Contamination If you have questions about this recall, Apotex Corp., 1 866.390-4411. April 2021 Class II Mometasone Furoate 00713070185 00713070153 CGMP Deviaitons If you have questions about this recall, Cosette Pharmaceuticals, Inc., 1 866.390-4411. April 2021 Class II Neomycin Sulfate 03982203105 Failed Stability If you have questions about this recall, X-Gen Pharmaceuticals Inc., 1-866-390-4411. April 2021 Class II Telmisartan 06233208730 Labeling: Label-mixup If you have questions about this recall, Alembic Pharmaceuticals Limited, 1-908-393-9604 April 2021 Class I Progesterone Capsules 04359835001 Failed Dissolution Specifications If you have questions about this recall, Dr. Reddy’s Laboratories, Inc., 1-888-375-3784 March 2021 Class II Metoclopramide Injection 0703450204 Chemical contamination If you have questions about this recall, Teva Pharmaceuticals USA 1-800-545-8800 March 2021 Class II Famotidine Tablets 06586286099 Presence of foreign tablets/capsules If you have questions about this recall, Aurobindo Pharma USA Inc. 1-866-850-2876 March 2021 Class II
Phenylephrine HCl 02502131501 Lack of Assurance of Sterility If you have questions about this recall, Sagent Pharmaceuticals Inc, 1- 866-625-1618 March 2021 Class II Gabapentin 05038331107 Failed Impurities/Degradation Specifications If you have questions about this recall, Akorn, Inc, 1-800-932-5676, Prompt 2 March 2021 Class II Nortriptyline HCL 06191985330 Failed Impurities/Degradation Specifications If you have questions about this recall, Direct Rx, 1-678-619-5510 March 2021 Class II Spironolactone Tablets 63629106701 Labeling: Label Mix-Up If you have questions about this recall, BRP Pharmaceuticals, 1- 877-885-0882 March 2021 Class II Daytrana (methylphenidate transdermal system) 06896855523 06896855533 06896855543 06896855553 Defective Delivery System: Out of specification for mechanical peel If you have questions about this recall, Noven Pharmaceuticals Inc, 1-305-253-5099 March 2021 Class II Omeprazole Delayed-Release Capsules 05199164310 Failed Impurities/Degradation Specifications If you have questions about this recall, Breckenridge Pharmaceutical, Inc, 1- 860-828-8140 March 2021 Class II
Omeprazole Delayed-Release Capsules 05140712910 Failed Impurities/Degradation Specifications If you have questions about this recall, Golden State Medical Supply Inc., 1-805-477- 9866 March 2021 Class II Fludeoxyglucose F 18 07631833450 Lack of Assurance of Sterility If you have questions about this recall, Massachusetts General Hospital PET Center, 1- 617-726-2000 March 2021 Class II Irinotecan Hydrochloride 05992371402 CGMP Deviations If you have questions about this recall, Areva Pharmaceuticals Inc 1-855-853-4760 March 2021 Class II Imatinib Mesylate 04359834490 00435984431 Failed Dissolution Specifications If you have questions about this recall, Dr. Reddy’s Laboratories, Inc. 1-888-375-3784 March 2021 Class II Epoprostenol Sodium 00703199501 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 March 2021 Class II Vecuronium Bromide 00703291401 00703291403 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 March 2021 Class II
Toposar 00703565701 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800 March 2021 Class II Metoclopramide Injection 00703450201 00703450204 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800. March 2021 Class II Leucovorin Calcium 00703514001 00703514501 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800. March 2021 Class II MethyIPREDNISolone Acetate 00703003101 00703005101 00703005104 00703004501 00703004301 00703006301 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800. March 2021 Class II Epoprostenol Sodium 00703198501 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800. March 2021 Class II Sterile Diluent for Epoprostenol Sodium 0703925801 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA 1-800-545-8800. March 2021 Class II
Desmopressin Acetate 00703505101 00703505103 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800. March 2021 Class II Dacarbazine 00703507501 00703507503 Lack of Assurance of Sterility If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800. March 2021 Class II Cisatracurium Besylate 07128871206 Labeling: Label mix-up If you have questions about this recall, Meitheal Pharmaceuticals Inc, 1-224-443-4617. March 2021 Class I BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz 05436540033 Non-sterility If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800. March 2021 Class I ChlroraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. Oz 05436540001 Non-sterility If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800. March 2021 Class I ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution – Hi- Lite Orange 0.10 fl. Oz Microbial Contamination Class I
05436540011 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl 05436540032 Non-sterility If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800. March 2021 Class I Meclizine HCl Tablets 05253612901 05253613301 Failed Dissolution Specifications If you have questions about this recall, Wilshire Pharmaceuticals, Inc, Ltd, 1-877-495-6856. February 2021 Class II Cephalexin for Oral Suspension 06787754568 CGMP Deviations If you have questions about this recall, Alkem Laboratories, Ltd, 1-636- 343-5664. February 2021 Class II Metformin Hydrochloride Extended-Release Tablets 02903305601 CGMP Deviations If you have questions about this recall, Nostrum Laboratories Inc, 1-816- 841-4636. February 2021 Class II Nortriptyline HCl Capsules 05167240011 CGMP Deviations If you have questions about this recall, Taro Pharmaceuticals U.S.A., Inc.,1-800-544-1449 ext 6066. February 2021 Class II
Acetaminophen Injection 05515030701 Discoloration and failed pH specifications If you have questions about this recall, AuroMedics Pharma LLC, 1-732-839-9400 ext 2. February 2021 Class II Ketorolac Tromethamine Injection 06332316201 Presence of Particulate Matter If you have questions about this recall, Fresenius Kabi USA, 1- 800-551-7176. February 2021 Class I Nitrofurantoin Capsules 06808444601 06808444611 Failed Dissolution Specifications If you have questions about this recall, American Health Packaging, 1-800- 707-4621. January 2021 Class II Chlorhexidine Gluconate 06809402861 cGMP Deviations If you have questions about this recall, Precision Dose Inc., 1-800-397- 9228. January 2021 Class II Metformin Hydrochloride 02903305601 cGMP Deviations If you have questions about this recall, Nostrum Laboratories Inc, 1-816- 308-4941. January 2021 Class II Paroex (Chlorhexidine Gluconate) 05237602102 05237602104 cGMP Deviations If you have questions about this recall, Sunstar Americas, Inc., 1-800-528- 8527 January 2021 Class II Levetiracetam 05038324116 Defective container If you have questions about this recall, Akorn, Inc, 1-800-932-5676, Prompt 2 January 2021 Class II
Cephalexin 06787754488 06787754468 Failed Impurity/Degradation Specifications If you have questions about this recall, Ascend Laboratories LLC, 1-877-272-7901. January 2021 Class II Esomeprazole Magnesium 06909752734 06909752834 06909752934 Cross-contamination with other products If you have questions about this recall, CIPLA, 1-866-604-3268. January 2021 Class II Cephalexin 06787754568 06909752734 Failed Impurity/Degradation Specifications If you have questions about this recall, Ascend Laboratories LLC, 1-877- 272-7901. January 2021 Class II Auryxia (ferric citrate) 05992263101 CGMP Deviations If you have questions about this recall, Akebia Therapeutics dba Keryx Biopharmaceuticals, Inc, 1-617-871-2098. December 2020 Class II Hydroxyzine Hydrochloride 06043215004 06043215016 Failed Impurities/Degradation Specification If you have questions about this recall, Morton Grove Pharmaceuticals, Inc., 1- 847-967-5600, Prompt 4. December 2020 Class II Vumerity (diroximel fumarate) 06440602001 Failed dissolution specifications If you have questions about this recall, Biogen MA Inc., 1-844- 477-4672. December 2020 Class II
Lansoprazole Delayed-Release 06838277177 Failed Dissolution Specifications If you have questions about this recall, Zydus Pharmaceuticals (USA) Inc, 1-877-993- 8779, Prompt 2. December 2020 Class II Lansoprazole Delayed-Release 06838277277 Failed Dissolution Specifications If you have questions about this recall, Zydus Pharmaceuticals (USA) Inc, 1-877-993- 8779, Prompt 2. December 2020 Class II Sildenafil 04229174801 Product mix-up If you have questions about this recall, AVKARE Inc., 1-855-361- 3993. December 2020 Class II TraZODONE Hydrochloride 04229183410 Product mix-up If you have questions about this recall, Shilpa Medicare Limited, 1-732-637-1971. December 2020 Class II Imatinib Mesylate 07248520330 GMP Deviations If you have questions about this recall, Shilpa Medicare Limited, 1-732-637-1971. December 2020 Class II
Imatinib Mesylate 07248520290d GMP Deviations If you have questions about this recall, Shilpa Medicare Limited, 1-732-637-1971. December 2020 Class II Anagrelide 01366846201 Failed Dissolution Specifications If you have questions about this recall, Torrent Pharma Inc, 1- 888-280-2040. December 2020 Class I (Lidocaine HCL 2%) Topical Anesthetic Hydrogel 06697710703 Microbial Contamination of Non- Sterile Drug Product If you have questions about this recall, MPM Medical LLC, 1-800- 232-5512. December 2020 Class I Chlorhexidine Gluconate 007016602715 Microbial contamination of non-sterile products If you have questions about this recall, Lohxa LLC, 1-800-641- 5564. December 2020 Class I Tizanidine 06787761415 Failed Dissolution Specifications If you have questions about this recall, Ascend Laboratories LLC, 1-877- 272-7901. December 2020 Class I Aripiprazole 00904651204 Failed Dissolution Specifications If you have questions about this recall, The Harvard Drug Group, 1- 800-875-0123. December 2020 Class II ARIPIPRAZOLE 06042944930 FAILED DISSOLUTION SPECIFICATIONS If you have questions about this recall, Golden December 2020 Class II
State Medical Supply Inc., 1-805-477-9866. Paroex (chlorhexidine gluconate) 05237602102 05237602104 Microbial Contamination of Non- sterile Product If you have questions about this recall, Sunstar Americas, Inc., 1-609-751- 9600. December 2020 Class I Levetiracetam 07193006352 Presence of foreign tablet If you have questions about this recall, Jubilant EYWA PHARMA INC, 1- 609-751-9600. December 2020 Class II clomiPRAMINE Hydrochloride 05974671130 Failed Tablet If you have questions about this recall, Jubilant Cadista Pharmaceuticals, Inc., 1-800-308-3985. December 2020 Class II Lansoprazole Delayed-Release Orally Disintegrating Tablets 06838277177 Failed Dissolution Specifications If you have questions about this recall, Zydus Pharmaceuticals, 1-877- 993-8779. November 2020 Class II Lansoprazole Delayed-Release Orally Disintegrating Tablets 06838277277 Failed Dissolution Specifications If you have questions about this recall, Zydus Pharmaceuticals, 1-877- 993-8779. November 2020 Class II Mesalamine Delayed-Release Tablets 00591224522 Failed Dissolution Specifications If you have questions about this recall, Teva Pharmaceuticals USA,1- 888-838-2872 ext 5 November 2020 Class II
metformin HCL ER 750 mg 04306390230 04306390260 CGMP Deviations If you have questions about this recall, PD-Rx Pharmaceuticals, Inc., 1- 800-299-7379 November 2020 Class II metformin HCL ER 500 mg tablets 07278900930 07278900960 07278900993 07278900990 CGMP Deviations If you have questions about this recall, PD-Rx Pharmaceuticals, Inc., 1- 800-299-7379 November 2020 Class II Metformin Hydrochloride Extended-Release Tablets 02903305501 CGMP Deviations If you have questions about this recall, Nostrum Laboratories Inc, 1-816- 841-4636. November 2020 Class II Metformin Hydrochloride Extended-Release Tablets 02903305601 CGMP Deviations If you have questions about this recall, Nostrum Laboratories Inc, 1-816- 841-4636. November 2020 Class II Chlorhexidine Gluconate 20% 05329600120 Discoloration If you have questions about this recall, Medichem S.A., 1-201- 420-1800 November 2020 Class II Metformin Hydrochloride Extended-Release Tablets 04948362401 CGMP Deviations If you have questions about this recall, Medichem S.A., 631-753- 9090 ext. 160 November 2020 Class II
Metformin Hydrochloride – Extended-Release Tablets 04948362309 04948362301 04948362350 04948362310 04948362350 CGMP Deviations If you have questions about this recall, Marksans Pharma Limited, 631-753-9090; ext. 160 November 2020 Class II Metformin HCL E/R 500 mg 07218906490 CGMP Deviations If you have questions about this recall, Direct Rx, 1-678-619-5510 November 2020 Class II Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 07093430930 07093430960 07093430990 07093430998 CGMP Deviations If you have questions about this recall, Denton Pharma, Inc., 1-800-722- 0772. November 2020 II Metformin Hydrochloride Extended-Release Tablets 07093433430 CGMP Deviations If you have questions about this recall, Denton Pharma, Inc., 1-800-722- 0772. November 2020 II Mesalamine Delayed-Release Tablets 04229156412 Failed Dissolution Specifications If you have questions about this recall, AVKARE Inc., 1-931-292-6222. November 2020 II
Metformin Hydrochloride Extended-Release 750 mg 70518248000 CGMP Deviations If you have questions about this recall, RemedyRepack Inc., 1- 866-845-3791 November 2020 II Hydrocortisone butyrate Cream, 0.1% 06868227015 SUBPOTENT DRUG If you have questions about this recall, Boehringer Ingelheim Pharmaceuticals, Inc., 1- 908-927-1400 November 2020 II Catapres (clonidine hydrochloride, USP) 0.3 mg 00597001101 An extraneous peak was observed for dissolution testing. If you have questions about this recall, Boehringer Ingelheim Pharmaceuticals, Inc., 1- 800-243-0127 November 2020 II Catapres (clonidine hydrochloride, USP) 0.2 mg 00597000701 An extraneous peak was observed for dissolution testing. If you have questions about this recall, Boehringer Ingelheim Pharmaceuticals, Inc., 1- 800-243-0127 November 2020 II Catapres (clonidine hydrochloride,USP) 0.1 mg 0597000601 An extraneous peak was observed for dissolution testing. If you have questions about this recall, Boehringer Ingelheim Pharmaceuticals, Inc., 1- 800-243-0127 November 2020 II NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 04219232701 Subpotent Drug If you have questions about this recall, Acella Pharmaceuticals, LLC1- 800-541-4802 ext 1, October 2020 I
NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 04219232801 Subpotent Drug If you have questions about this recall, Acella Pharmaceuticals, LLC1- 800-541-4802 ext 1, October 2020 I Losartan Pot/HCTZ 50/12.5 mg 06191904090 CGMP Deviations If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 October 2020 II RIOMET ER (metformin hydrochloride for extended-release oral suspension) 01063101917 CGMP Deviations If you have questions about this recall, Sun Pharmaceutical Industries, Inc., 1-800-818-4555 October 2020 II Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035% 05977992001 CGMP Deviations If you have questions about this recall, Akorn, Inc, 1-800-932-5676. October 2020 II Potassium Chloride Extended-Release Tablets 06438086006 Failed Dissolution Specifications If you have questions about this recall, Strides Inc.1-609-773- 5000. October 2020 II Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg 68788760509 Subpotent Drug If you have questions about this recall, Preferred Pharmaceuticals, Inc. 1- 714-777-3729. September 2020 II
Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg 68788760409 68788760401 Subpotent Drug If you have questions about this recall, Preferred Pharmaceuticals, Inc. 1- 714-777-3729. September 2020 II Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg 68788686009 Subpotent Drug If you have questions about this recall, Preferred Pharmaceuticals, Inc. 1- 714-777-3729. September 2020 II Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch 68788928301 Subpotent Drug If you have questions about this recall, Preferred Pharmaceuticals, Inc. 1- 714-777-3729. September 2020 II WP Thyroid, Westhroid Pure, 2 Grain (130 mg) Thyroid USP 06472759502 06472759504 06472759505 06472759506 06472759501 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP 06472761502 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II
06472761504 06472761505 06472761506 06472761501 WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP 06472758502 06472758504 06472758505 06472758506 06472758501 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II WP Thyroid, Westhroid Pure, 1.25 Grain (81.25 mg) Thyroid USP 06472760502 06472760504 06472760505 06472760506 06472760501 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II WP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thyroid USP 06472757502 06472757504 06472757505 06472757506 06472757501 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II
WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP 06472755502 06472755504 06472755505 06472755506 06472755501 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg 06472754504 06472754505 06472754506 06472754501 06472754502 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II Nature-Throid, Thyroid USP [liothyronine (T3) 27 mcg and levothyroxine (T4) 114 mcg 06472733124 06472733125 06472733126 06472733121 06472733122 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II Nature-Throid, Thyroid USP [liothyronine (T3) 22.5 mcg and levothyroxine (T4) 95 mcg 06472733104 06472733105 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II
06472733106 06472733101 06472733102 Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg 06472733094 06472733095 06472733096 06472733091 06472733092 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II Nature-Throid, Thyroid USP [liothyronine (T3) 18 mcg and levothyroxine (T4) 76 mcg 06472733084 06472733085 06472733086 06472733081 06472733082 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II Nature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg 06472733074 06472733075 06472733076 06472733071 06472733072 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II
Nature-Throid, Thyroid USP [liothyronine (T3) 13.5 mcg and levothyroxine (T4) 57 mcg 06472733054 06472733055 06472733056 00472733051 06472733052 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II Nature-Throid, Thyroid USP [liothyronine (T3) 11.25 mcg and levothyroxine (T4) 47.5 mcg], 1.25 Grain (81.25 mg) 06472733034 06472733035 06472733036 06472733031 06472733032 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II Nature-Throid, Thyroid USP [liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg 06472732994 06472732995 06472732996 06472732991 06472732992 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II
Nature-Throid, Thyroid USP [liothyronine (T3) 6.75 mcg 06472733024 06472733025 06472733026 06472733021 06472733022 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II Nature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38 mcg 06472733004 06472733005 06472733006 06472733001 06472733002 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 II Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg 06472733054 06472733055 06472733056 06472733051 06472733051 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 I Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levothyroxine (T4) 76 mcg 06472733084 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 I
06472733081 Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg 06472733031 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 I Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, Levothyroxine (T4) 28.5 mcg 06472733021 06472733022 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 I Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg 06472732996 06472732991 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 I WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg 06472755504 06472755506 06472755501 Subpotent Drug If you have questions about this recall, RLC Labs Inc., 1-877-797-7997 September 2020 I
Sulfamethoxazole and Trimethoprim Tablets Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s). If you have questions about this recall, Aurobindo Pharma USA Inc., 1-866-850-2876 September 2020 II BusPIRone Hydrochloride Tablets Failed Impurity /Degradation Specifications If you have questions about this recall, Par Pharmaceutical Inc., 1-845-573-5500 September 2020 II Buprenorphine HCl Injection Sub-potent Drug: Out-of-Specification assay results found at 3-month stability testing. If you have questions about this recall, West-Ward Pharmaceuticals , 1-877-845-0689. September 2020 II Metformin Hydrochloride Extended-Release Tablets 07638512810 CGMP Deviations If you have questions about this recall, BAYSHORE PHARMACEUTICALS, 1- 877-372-6093 September 2020 II Metformin Hydrochloride Extended-Release Tablets 07638512901 CGMP Deviations If you have questions about this recall, BAYSHORE PHARMACEUTICALS, 1- 877-372-6093 September 2020 II Cephalexin for Oral Suspension 00093417773 Labeling: Label Error on Declared Strength If you have questions about this recall, Teva Pharmaceuticals USA,1- 888-838-2872 ext 5 September 2020 II
Lidocaine Patch 5% 00591352530 Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton If you have questions about this recall, Teva Pharmaceuticals USA,1- 888-838-2872 ext 5 August 2020 II Mibelas 24 Fe 06818091113 Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test If you have questions about this recall, Lupin Pharmaceuticals Inc.1- 410-576-2000 ext 3 August 2020 II Nystatin Oral Suspension 00121061016 Subpotent drug: Out of specification for assay at the 15-month test interval If you have questions about this recall, PAI Holdings, LLC. dba Pharmaceutical Associates Inc1-864-277- 7282 ext 0 August 2020 II Ear Pain MD Pain Relief Drops 07242900708 cGMP Deviations. If you have questions about this recall, Eosera, Inc.1-844-732-7929 August 2020 II Ear Pain MD Pain Relief Drops 07242900722 cGMP Deviations. If you have questions about this recall, Eosera, Inc.1-844-732-7929 August 2020 II
Heparin Sodium 70004065046 Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. If you have questions about this recall, SCA Pharmaceuticals1-877- 550-5059 August 2020 II BD ChloraPrep Clear 5436540032213 Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides If you have questions about this recall, CareFusion LLC1-201- 847-6800. August 2020 I ChloraPrep With Tint 05436540011 Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides If you have questions about this recall, CareFusion LLC1-201- 847-6800. August 2020 I ChlroraPrep One-Step 05436540001 Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides If you have questions about this recall, CareFusion LLC1-201- 847-6800. August 2020 I
DDAVP Nasal 05556625000 Superpotent Drug If you have questions about this recall, Ferring Pharmaceuticals Inc1- 888-337-7464 ext2 August 2020 I Desmopressin Acetate 06991850105 Superpotent Drug If you have questions about this recall, Ferring Pharmaceuticals Inc1- 888-337-7464 ext2 August 2020 I STIMATE (desmopressin acetate) 00053687100 Superpotent Drug If you have questions about this recall, Ferring Pharmaceuticals Inc1- 888-337-7464 ext2 August 2020 I Hydrochlorothiazide 16729018317 CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545. August 2020 II
Hydrochlorothiazide (HCTZ) 29300012810 CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545. August 2020 II Hydrochlorothiazide 16729018417 CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545. August 2020 II Thyroid 1 Grain 64727330002 CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545. August 2020 II Thyroid 1 Gr 64727330001 CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545. August 2020 II Thyroid Neutral 64727330802 CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545. August 2020 II Topiramate 47335070713 CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545. August 2020 II
Phendimetrazine 00702007710 CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545. August 2020 II Phendimetrazine 69543041011 CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545. August 2020 II Phendimetrazine 69543040911 CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545. August 2020 Class II Prednisone 00527293137 Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets If you have questions about this recall, Lannett Company, Inc.1-215-333- 9000 August 2020 Class II Elitek (rasburicase) 00024515175 Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing If you have questions about this recall, .Sanofi- Aventis U.S. LLC1-800- 981-2491 ext 2 August 2020 Class II
Mibelas 24 Fe 06818091111 Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test If you have questions about this recall, Lupin Pharmaceuticals Inc.1- 410-576-2000 ext 3 August 2019 Class II Daptomycin 06745781350 Presence of Particulate Matter If you have questions about this recall, Mylan Institutional LLC, 1-800- 796-9526 ext 1. August 2020 Class II Fentanyl Citrate 00409909412 Lack of Assurance of Sterility If you have questions about this recall, Pfizer Inc.,1-800-438-1985. August 2020 Class II Lisinopril 06800133408 Presence of Foreign Tablets/Capsules If you have questions about this recall, Lupin Pharmaceuticals Inc., 1- 866-587-4617 ext 2. August 2020 Class II Cefdinir 06818072320 Superpotent Drug If you have questions about this recall, Lupin Pharmaceuticals Inc., 1- 866-587-4617 ext 2. July 2020 Class II Metformin HCl Extended Release Tablets CGMP Deviation If you have questions about this recall, Preferred Pharmaceuticals, Inc, 1- 714-777-3729. July 2020 Class II Metformin Hydrochloride Extended-Release 00904579461 CGMP Deviation If you have questions about this recall, The Time-Cap, Labs Inc, 1- 631-753-9090 ext 160 July 2020 Class II
Clozapine Tablets 06586284605 Presence of foreign tablet If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876 July 2020 Class II Metformin Hydrochloride Extended-release Tablets 06818033607 CGMP Deviations If you have questions about this recall, Lupin Pharmaceuticals Inc., 1- 866-587-4617. July 2020 Class II Aripiprazole Tablets 06233209730 Labeling: Label mix up If you have questions about this recall, Alembic Pharmaceuticals Limited, 1-908-393-9604. July 2020 Class II Nystatin Cream 00316022130 00316022115 Subpotent Drug If you have questions about this recall, Crown Laboratories, Inc., 1-800- 877-8869. July 2020 Class II metFORMIN HCL ER 07278900930 07278900960 07278900990 07278900993 49483062301 CGMP Deviations If you have questions about this recall, Amneal Pharmaceuticals., 1-833- 582-0812. July 2020 Class II Metformin Hydrochloride Extended-Release Tablets 04948362301 CGMP Deviations If you have questions about this recall, Time- Cap Labs,1-631-753-9090 ext 160 July 2020 Class II
Metformin Hydrochloride Extended – Release Tablets 06203757101 06203757110 06203757701 06203757710 CGMP Deviations If you have questions about this recall, Teva Pharmaceuticals USA, 1- 800-545-8800. July 2020 Class II Metformin Hydrochloride Extended-Release Tablets 53746017801 06516217809 06516217850 06516217810 53746017901 06516217910 00537460178 53746017805 53746017810 65162017811 00537460179 65162017901 CGMP Deviations If you have questions about this recall, Amneal Pharmaceuticals, 1-833- 582-0812 July 2020 Class II Heparin Sodium 70004065046 Subpotent Drug If you have questions about this recall, SCA Pharmaceuticals, 1-877- 550-5059. June 2020 Class II Irinotecan HCL Injection 00143958301 Defective Container If you have questions about this recall, West- Ward Pharmaceutical Corp, 1-877-845-0689. June 2020 Class II
Irinotecan HCL Injection 00143970101 Defective Container If you have questions about this recall, West- Ward Pharmaceutical Corp, 1-877-845-0689. June 2020 Class II metFORMIN HCL ER 04306342830 04306342860 04306342890 04306342898 04306342893 53746017805 CGMP Deviations If you have questions about this recall, Amneal Pharmaceuticals, 1-833- 582-0812 June 2020 Class II Metformin Hydrochloride Extended-Release Tablets 05026853115 04229161090 04229161018 04229161036 04229161010 CGMP Deviations If you have questions about this recall, AVKARE Inc., 1-931-292-6222. June 2020 Class II Metformin Hydrochloride Extended-Release Tablets 04229161190 04229161118 04229161150 CGMP Deviations If you have questions about this recall, AVKARE Inc., 1-931-292-6222. June 2020 Class II Metformin Hydrochloride Extended-Release Tablets 06050502601 CGMP Deviations If you have questions about this recall, Apotex Inc., 1-800-268-4623. June 2020 Class II
Gaviscon Liquid Antacid Extra Strength, Cool Mint 00135009541 Labeling: Label lacks warning If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-743- 4014 June 2020 Class II Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry 00135057441 Labeling: Label lacks warning If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-743- 4014 June 2020 Class II Gaviscon Regular Strength Liquid Antacid Cool Mint 00135009441 Labeling: Label lacks warning If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-743- 4014 June 2020 Class II Gaviscon Regular Strength Liquid Antacid Cool Mint 00135009442 Labeling: Label lacks warning If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-743- 4014 June 2020 Class II oxyTOCIN 30 Units 070092106807 Subpotent drug If you have questions about this recall, QuVa Pharma, Inc., 1-888-339- 0874. June 2020 Class II
Lisinopril 06818051303 Product Mix Up If you have questions about this recall, Lupin Pharmaceuticals Inc., 1- 866-587-4617. June 2020 Class II Unasyn (ampicillin sodium/sulbacatam) 00049001381 00049001383 Presence of Particulate Matter If you have questions about this recall, Pfizer Inc., 1-800-879-3477. June 2020 Class II Doxycycline Hyclate 06258469311 Failed dissolution specification If you have questions about this recall, American Health Packaging, 1-614- 492-8177. June 2020 Class II Ketorolac Tromethamine 06332316200 06332316203 Presence of Particulate Matter If you have questions about this recall, Fresenius Kabi USA, LLC, 1-847-550-2300. June 2020 Class II Doxycycline Hyclate 00904043004 00904043006 Failed Dissolution Specification If you have questions about this recall, The Harvard Drug Group, 1- 732-542-1191. June 2020 Class II Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 00555097102 00555097302 00555077702 Some bottles may contain mixed strengths of the product. If you have questions about this recall, Teva Pharmaceuticals USA, 1- 800-545-8800. June 2020 Class II
Estriol USP Micronized 71092997702 Failed impurities/ degradation specifications If you have questions about this recall, TRIOVA PHARMACEUTICALS LLC, 1-539-777-0720. June 2020 Class II NP Thyroid 90 04219233101 Superpotent Drug If you have questions about this recall, Acella Pharmaceuticals, LLC 1- 800-541-4802. June 2020 Class I NP Thyroid 60 04219233001 Superpotent Drug If you have questions about this recall, Acella Pharmaceuticals, LLC 1- 800-541-4802. June 2020 Class I NP Thyroid 30 04219232901 Superpotent Drug If you have questions about this recall, Acella Pharmaceuticals, LLC 1- 800-541-4802. June 2020 Class I Doxycycline Hyclate tablets 05528986606 05528986610 05528986614 05528986620 05528986628 05528986630 05528986660 05528986698 05528986671 05528986687 05528986674 Failed dissolution specifications If you have questions about this recall, PD-Rx Pharmaceuticals, Inc., 1- 800-299-7379. June 2020 Class II
Doxycycline Hyclate Tablets 00143211250 00143211205 Failed dissolution specification If you have questions about this recall, West- Ward Columbus Inc, 1- 877-845-0689. June 2020 Class II Lactated Ringers 0409795309 Presence of Particulate Matter If you have questions about this recall, Hospira Inc., 1-877-946-7747. May 2020 Class II Aloprim (allopurinol sodium) 06745718750 Discoloration If you have questions about this recall, Mylan Pharmaceuticals Inc., 1- 551-233-2700. May 2020 Class II Infuvite PEDiatric Pharmacy 05464356470 Defective container If you have questions about this recall, Sandoz, Inc, 1-609-627-8500 May 2020 Class II Epinephrine Injection 00093598627 CGMP Deviations If you have questions about this recall, Teva Pharmaceuticals USA, 1- 888-838-2872. May 2020 Class II Nizatidine 06084630115 CGMP Deviations If you have questions about this recall, Amneal Pharmaceuticals of New York, 1-631-952-0214 May 2020 Class II Ceftazidime 00264314511 Failed Stability Specifications If you have questions about this recall, Braun Medical Inc., 1-949-660- 2000 May 2020 Class II
Lisinopril Tablets 68180098103 Product Mix-Up If you have questions about this recall, Lupin Pharmaceuticals Inc., 1- 866-587-4617 April 2020 Class II Cefixime for Oral Suspension 06818040501 Subpotent Drug If you have questions about this recall, Lupin Pharmaceuticals Inc., 1- 866-587-4617 April 2020 Class II Daytrana 06896855553 Defective Delivery System If you have questions about this recall, Noven Therapeutics, LLC, 1-305- 253-5099. April 2020 Class II Daytrana 06896855543 Defective Delivery System If you have questions about this recall, Noven Therapeutics, LLC, 1-305- 253-5099. April 2020 Class II Daytrana 06896855523 Defective Delivery System If you have questions about this recall, Noven Therapeutics, LLC, 1-305- 253-5099. April 2020 Class II Acetaminophen and Codeine Phosphate 01310705801 CGMP Deviations If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876. April 2020 Class II Acetaminophen and Codeine Phosphate 01310705999 CGMP Deviations If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876. April 2020 Class II
Acetaminophen and Codeine Phosphate 01310706001 CGMP Deviations If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876. April 2020 Class II Gabapentin Capsules 06586219899 CGMP Deviations If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876. April 2020 Class II Levetiracetam Tablet 06586224708 CGMP Deviations If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876. April 2020 Class II Simvastatin 06586205390 CGMP Deviations If you have questions about this recall, Aurobindo Pharma USA, Inc 1-866-850-2876. April 2020 Class II Mirtazapine 01310703134 06586219899 CGMP Deviations If you have questions about this recall, Aurobindo Pharma USA, Inc 1-866-850-2876. April 2020 Class II Phentermine Hydrochloride 06586205390 06586219899 CGMP Deviations If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876. April 2020 Class II Oxycodone and Acetaminophen 01310704601 6586219899 CGMP Deviations If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876. April 2020 Class II
Losartan Potassium 06042931630 06042931690 06042931610 CGMP Deviations If you have questions about this recall, Golden State Medical Supply Inc., 1-805-477-9866 Ext 4. April 2020 Class II Estradiol 06327599008 06327599005 06327599004 CGMP Deviations If you have questions about this recall, B & B Pharmaceuticals, Inc., 1- 800-499-3100. April 2020 Class II Acetaminophen and Codeine Phosphate 300/30mg 52959000310 52959000312 52959000314 52959000315 52959000316 52959000320 52959000330 52959000360 CGMP Deviations If you have questions about this recall, H.J. Harkins Co, 1-805-929- 1333 April 2020 Class II succinylcholine Chloride 07101934104 lack of sterility assurance. If you have questions about this recall, PharMEDium Services, 1- 800-523-7749 Option 1 April 2020 Class II rocuronium Bromide 07101932110 07101932105 lack of sterility assurance. If you have questions about this recall, PharMEDium Services, 1- 800-523-7749 Option 1 April 2020 Class II
Phytonadione Injectable Emulsion 04359840511 Defective Container If you have questions about this recall, Dr. Reddy’s Laboratories Inc., 1-888-375-3784 April 2020 Class I nICARdipine HCl 07101920601 lack of sterility assurance. If you have questions about this recall, PharMEDium Services, 1- 800-523-7749 Option 1 April 2020 Class II Losartan Potassium tablets 00591374500 00591374600 00591374700 CGMP Deviations If you have questions Teva Pharmaceuticals USA, 1-888-483-8279 April 2020 Class II Losartan Potassium tablets 02315564503 02315564509 02315564510 02315564509 02315564603 02315564609 02315564610 CGMP Deviations If you have questions Avet Pharmaceuticals, Inc., 1-800-967-5952 Option 1 April 2020 Class II Lisinopril Tablets 06818098201 Presence of Foreign Tablet/ Capsule If you have questions about this recall, Lupin Pharmaceuticals Inc., 1-800-399-2561 April 2020 Class II
HYDROmorphone in 0.9% Sodium Chloride HCl 06155316644 lack of sterility assurance. If you have questions about this recall, PharMEDium Services, 1- 800-523-7749 Option 1 April 2020 Class II Glycopyrrolate Tablets 49884006501 lack of sterility assurance. If you have questions about this recall, Par Pharmaceutical Inc., 1- 845-573-5500 April 2020 Class II fentaNYL Citrate Injection 06155330633 06155330328 lack of sterility assurance. If you have questions about this recall, PharMEDium Services, LLC, 1-800-523-7749 Option 1 April 2020 Class II fentaNYL Citrate 06155311350 06155367244 lack of sterility assurance. If you have questions about this recall, PharMEDium Services, LLC, 1-800-523-7749 Option 1 April 2020 Class II ePHEDrine Sulfate 07103000312 07103000309 07103000302 07103000109 lack of sterility assurance. If you have questions about this recall, PharMEDium Services, LLC, 1-800-523-7749 Option 1 April 2020 Class II C-*Vancomycin Opthal 14 mg drops 67457034001 Lack of Assurance of Sterility If you have questions about this recall, Medical Center Pharmacy, Inc., 1- 800-523-7749 April 2020 Class II
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL 63323001002 Lack of Assurance of Sterility If you have questions about this recall, Medical Center Pharmacy, Inc., 1- 800-523-7749 April 2020 Class II C-*Albumin Eye Drop 10% S 44206025105 Lack of Assurance of Sterility If you have questions about this recall, Medical Center Pharmacy, Inc., 1- 800-523-7749 April 2020 Class II *Morphine 2 mg/mL Cassette 00409113403 Lack of Assurance of Sterility If you have questions about this recall, Medical Center Pharmacy, Inc., 1- 800-523-7749 April 2020 Class II *Mitomycin 0.04% Ophth DR eye drops 067457051805 Lack of Assurance of Sterility If you have questions about this recall, Medical Center Pharmacy, Inc., 1- 800-523-7749 April 2020 Class II Nystatin Oral Suspension 00 21081016 SubPotent Drug: Low out-of- specification results for assay testing. If you have questions about this recall, PAI Holdings, LLC. dba Pharmaceutical Associates Inc, 1-864- 277-7282. April 2020 Class II Theophylline (Anhydrous) Extended-Release 02903300101 CGMP Deviations: poor manufacturing practices resulted in Labeling If you have questions about this recall, Jubilant Draximage Inc, 1-800- 361-2356. April 2020 Class II
DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION) 06517428805 06717528830 Failed Stability Specifications If you have questions about this recall, Nostrum Laboratories Inc, 1-816- 841-4636. April 2020 Class II Advil Liqui-Gel Mini 160+20+20 CT 00573171559 Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings, +44 20 8047 5000. April 2020 Class II Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 00573019175 00573019150 Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings, +44 20 8047 5000. April 2020 Class II Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis 00573176989 00573176995 Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings, +44 20 8047 5000. April 2020 Class II Advil Allergy & Congestion Relief 00573019610 Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. If you have questions about this recall, Glaxosmithkline Consumer Healthcare April 2020 Class II
Holdings, +44 20 8047 5000. Phenylephrine 10 mg tablets. 00573019620 Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings, +44 20 8047 5000. April 2020 Class II Ibuprofen 200 mg Chlorpheniramine Maleate 4mg 00573019610 Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings, +44 20 8047 5000. April 2020 Class II Doxycycline 06330461501 06330461650 CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. If you have questions about this recall, Sun Pharmaceutical Industries, Inc., 1-800-818-4555. March 2020 Class II Solifenacin Succinate 05199189333 05199189390 CGMP Deviations: During manufacturing, Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. If you have questions about this recall, Breckenridge Pharmaceutical, Inc, 1- 860-828 – 8140. March 2020 Class II Atorvastatin Calcium 06330482905 Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg. If you have questions about this recall, Sun Pharmaceutical Industries, Inc., 1-800-818-4555. March 2020 Class II
Pantoprazole Sodium Delayed-Release CGMP Deviations: Presence of dark brown discoloration on edges of tablets If you have questions about this recall, Jubilant Cadista Pharmaceuticals, Inc., 1-410- 860-2836. March 2020 Class II Sotalol HCL 00378512301 Presence of particulate matter. presence of metal particles. If you have questions about this recall, Mylan Pharmaceuticals Inc., 1- 551-233-2700. March 2020 Class II Daytrana (methylphenidate transdermal system) 06896855523 06896855533 06896855543 06896855553 Defective Delivery System: Out of specification for mechanical peel and shear. If you have questions about this recall, Noven Therapeutics, LLC, 1 – 800-796-9526. March 2020 Class II Ranitidine 00113785282 05977954082 03780850782 02113011682 00363085282 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II Ranitidine 05977995001 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II Ranitidine 00113785201 06839185256 05977954001 05591001101 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II
06398185256 03014260056 04125085201 01182208524 00363085201 Ranitidine 04903580075 01167395075 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II Ranitidine 04903560875 01167302375 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II Ranitidine 00113795009 05977995009 04903580009 04612253309 03014289109 03680095009 01167395009 00363095009 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II Ranitidine 04152039209 05977954009 05531985209 04612253209 03780850709 04934810954 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II
0 4125089109 01182208523 03701285209 05059485209 04934810954 01167385209 00363085209 Ranitidine 05591085271 04612222471 00113085271 06925604171 03014260071 00904671651 04125085271 05606209971 01182208522 02113011671 03680085271 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II Ranitidine 01167395058 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II Ranitidine 04125095002 01182209500 03701295062 02113056862 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II
03680095062 00363095002 Ranitidine 04699485262 04152039202 05977954002 05591085202 04116385262 04903560802 05530185202 05531985202 04612222462 00113085262 06925604162 04934810904 03014260002 00904671624 04125085202 05606209902 01182208525 01020285262 04119085262 03701285262 02113011602 05059485202 06201102821 03680085202 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II
01167302302 00363085262 Ranitidine 00113085251 00363085251 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II Ranitidine 06984229306 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II Ranitidine 03780887647 04903587647 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II Ranitidine 03780887647 04903587647 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II Ranitidine 00113787627 07000003752 01167387627 00363187627 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II
Ranitidine 06201102832 09046715524 00125025272 04934813612 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II Ranitidine 06984229365 04116393165 05531987665 00113087665 03780887665 06925687665 06201102831 06201102831 00904671546 02113011865 04934813644 01167387665 00363187665 CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine. If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260 March 2020 Class II Lisinopril/HCTZ 68180051902 70518038203 Presence of Foreign Tablets/Capsules If you have questions about this recall, RemedyRepack Inc., 1- 866-845-3791 March 2020 Class II Calcium Chloride Injection 07128302253 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE 07128302103 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE 07128302243 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE 07128302513 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Elelyso (taliglucerase alfa) for injection 069010601 Lack of Assurance of Sterility If you have questions about this recall, Pfizer Labs, 1-877-225-9750 March 2020 Class II Mesalamine Delayed-Release Tablets591224522 Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing. If you have questions about this recall, Teva Pharmaceuticals USA, Inc, 1-877-685-8222 March 2020 Class II Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA7 0128306282 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA 07128306341 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP For IM IA 7128306251 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA7128306352 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA7128306331 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE ACET/BUPIVACAINE HCL Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II
[10ML] 40MG/5MG/ML INJ SUSP, For IM, IA 07128306321 Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE 07128305302 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA 07128306331 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA 07128306352 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II
07128306251l Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE7128305312 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE 07128305301 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Selenium Injection, SELENIUM 200MCG/ML INJECTABLE 07128302273 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Super MIC Injection, SUPER MIC* INJECTABLE 07128302343 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 20 MG/ML INJECTABLE Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II
07128303361 Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE 07128314135 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE 07128302163 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE 07128303061 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/ 5MG/ML INJECTABLE 07128302313 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II
Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE 07128308128 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II MIC-PLEX Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/ 5MG/ML INJECTABLE7128302333 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE7128302303 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 50 MG/ML INJ SUSP, For IM, IA 07128306361 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 100 MG/ML INJ SUSP 07128306191 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II
Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension 07128306241 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE (PF) CMC [2ML] 80 MG/ML INJ SUSP, For IM, IA 07128306392 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIV [10ML] CMC 40MG/5MG/ML INJ SUSP, For IM, IA 07128306231 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For IV, IM 07128303383 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II
Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE 07128303313 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE 07128303423 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE 07128392603 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE 07128310115 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE 0712830603 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II
07128305325 Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE 07128303413 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE 07128305331 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Glycine Injection, GLYCINE USP 50MG/ML INJECTABLE 07128303443 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Glycerin (PF) Injection, GLYCERIN 99% INJECTABLE 07128304641 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE 07128312313 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II
Hydroxocobalamin Injection, HYDROXOCOBALAMIN 5MG/ML INJECTABLE 07128303393 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE 07128312313 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE 07128302143 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP 07128306301 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP 07128306301 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Deoxycholic Acid Sodium Injection, DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE 07128304623 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Cyanocobalamin Injection 07128303303 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV March 2020 Class II
Pharmaceuticals, Inc, 1- 877-685-8222 Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE 07128303333 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN 07128304111 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM 07128302203 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [5ML] 7MG/ML INJ SUSP, For IM, IA 07128306215 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II
BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [10ML] 7MG/ML INJ SUSP, For IM, IA 07128306211 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, 07128306202 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II B-COMPLEX 110 INJECTABLE 07128302123 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable0 7128302265 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable 07128302263 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 07128305462 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 07128305452 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Alprostadil (prostaglandin E1) 80 MCG/ML Injectable 07128305432 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Alprostadil (prostaglandin E1)150 MCG/ML Injectable 027128305382 Patent ductus arteriosus If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection 07128305502 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection 07128305492 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection 07128305472 Lack of Assurance of Sterility If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222 March 2020 Class II Phenytoin Oral Suspension 05167240691 Resuspension Problems If you have questions about this recall, Taro Pharmaceuticals U.S.A, 1- 866-923-4914. March 2020 Class II Glycopyrrolate Tabs 00615817039 Failed Impurities If you have questions about this recall, NCS Healthcare of Kentucky Inc, 1-270-651-6188 February 2020 Class II Desmopressin Acetate Tablets 06808460421 GMP Deviations If you have questions about this recall, American Health Packaging, 1-800- 967-5952. February 2020 Class II Desmopressin Acetate Tablets 06808460621 GMP Deviations If you have questions about this recall, American Health Packaging, 1-800- 967-5952. February 2020 Class II
Lamotrigine 05167241311 Cross contamination If you have questions about this recall, Taro Pharmaceuticals U.S.A, 1- 866-923-4914. February 2020 Class II Methylphenidate hydrochloride Extended-Release 06203772501 Product bottle may be absent of desiccant. If you have questions about this recall, Teva Pharmaceuticals, 1-888- 838-2872. February 2020 Class II Fentanyl Citrate Inj 0409909412 Defective container If you have questions about this recall, Pfizer Inc, 1-800-879-3477. February 2020 Class II Ethacrynate Sodium for Injection 06838224601 cGMP Deviations If you have questions about this recall, Zydus Pharmaceuticals, 1-877- 993-8779. February 2020 Class II Caduet (amlodipine besylate/atorvastatin calcium) 00069218030 Defective container If you have questions about this recall, Pfizer Inc, 1-800-879-3477. February 2020 Class II Hydrocortisone and Acetic Acid Otic 05038390110 Subpotent Drug If you have questions about this recall, TECH PHARMACAL CO., INC, 1-800-932-5676. February 2020 Class II Ranitidine Hydrochloride 04306384414, 04306384430, 04306384490, 04306384401 cGMP Deviations If you have questions about this recall, PD-Rx Pharmaceuticals, Inc., 1- 405-942-3040. February 2020 Class II
Olmesartan Medoxomil Tablets 06787744690 cGMP Deviations If you have questions about this recall, Ascend Laboratories LLC, 1-201- 476-1977. February 2020 Class II Atorvastatin Calcium Tablets 07037702711 Presence of Foreign Tablets If you have questions about this recall, Graviti Pharmaceuticals Private Limited, 040 6815 5555. February 2020 Class II Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10% 00363013711 Presence of Foreign Substance If you have questions about this recall, Shandex Personal Care Manufacturing Inc., 1-613- 267-1881 February 2020 Class II Nystatin Oral Suspension 00121081016 Subpotent If you have questions about this recall, Pharmaceutical Associates Inc, 1-864- 277-7282. February 2020 Class II Ranitidine Tablets 70518171400 CGMP Deviation If you have questions about this recall, RemedyRepack Inc, 1- 866-845-3791. January 2020 Class II Ranitidine Tablets 06878873883, 06878873889, 06878873881, 06878863821, 06878863823, 06878863829, Trace amounts of an impurity If you have questions about this recall, Preferred Pharmaceuticals, Inc, 1- 714-777-3729. January 2020 Class II
06878863820 Nizatidine Capsules 00378515091, 00 378530093 Trace amounts of an impurity If you have questions about this recall, Mylan Pharmaceuticals Inc, 1- 304-599-2595. January 2020 Class II Ranitidine Tablets 52959050207 52959050214 52959050220 52959050230 52959050260 Trace amounts of an impurity If you have questions about this recall, H.J. Harkins Company, Inc, 1- 800-841-5554. January 2020 Class II Ranitidine Tablets 07093401704, 07093401720, 07093401724, 07093401730, 07093401790, 07093428715, 07093428790 Trace amounts of an impurity If you have questions about this recall, Denton Pharma, Inc., 1-800-722- 0772. January 2020 Class II Netspot 06948800140 Defective container If you have questions about this recall, Advanced Accelerator Applications USA, Inc., 1- 862-263-0820. January 2020 Class II
Estriol USP Micronized 62991215906, 62991215903, 62991215905, 62991215902 Subpotent If you have questions about this recall, Letco Medical LLC, 1-800-239- 5288. January 2020 Class II Dutasteride 5026828213 cGMP Deviations If you have questions about this recall, AvKARE, Inc, 1-931-292-6222 January 2020 Class II Testosterone Cypionate 06275601740,06275601540, 06275601640 cGMP Deviations If you have questions about this recall, Sun Pharmaceutical Industries, Inc., 1-609-495-2800. January 2020 Class II Sumatriptan Succinate 06275652169, 06275652188 Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. If you have questions about this recall, Sun Pharmaceutical Industries, Inc., 1-609-495-2800. January 2020 Class II Ranitidine 06255969060, 06255969005 Impurities If you have questions about this recall, Appco Pharma LLC, 1-732-253- 7735. January 2020 Class II Ranitidine 03780819601,03780819604 Impurities If you have questions about this recall, AAA Pharmaceutical, Inc, 1- 609-288-6060. January 2020 Class II Blisovi Fe 1.5/30 06818086611 Failed tablet If you have questions about this recall, Lupin Pharmaceuticals Inc, 1- 410-576-2000. January 2020 Class II
Estriol 07642004936,07642004937, 07642004938 Presence of impurities If you have questions about this recall, Asclemed USA Inc, 1-310- 320-0100. January 2020 Class II Ranitidine 06846224860,68486224860, 06846224801, 68486224860, 06846224930, 68486224860, 06846224901, 68486224860, 06846224920, 68486224860, 06846224805, 68486224860 Presence of impurities If you have questions about this recall, Glenmark Pharmaceuticals Inc, 1-888-721-7115 January 2020 Class II Ranitidine 06220777332 Presence of impurities If you have questions about this recall, Granules India Limited, 1-877-770- 3183. January 2020 Class II Myorisan® 0 6174830213 Unit dose mispackaging If you have questions about this recall, Akorn, Inc, 1-800-932-5676. January 2020 Class II Ranitidine 06068726069 Presence of impurities If you have questions about this recall, American Health Packaging, 1-800- 707-4621. January 2020 Class II Amantadine Hydrochloride 5974669901 Presence of foreign substance If you have questions about this recall, Jubilant Cadista Pharmaceuticals, Inc. 1-410-860-8500 December 2019 Class II
25% Dextrose® 00409177510 Labeling error If you have questions about this recall, Pfizer Inc1-877-225-9750 December 2019 Class II Vancomycin Hydrochloride 05515020420 Product discoloration If you have questions about this recall, AuroMedics Pharma LLC, 888-238-7880. December 2019 Class II Lidocaine Hcl 70004072309 Presence of foreign substance If you have questions about this recall, SCA Pharmaceuticals, LLC, 1- 877-550-5059. December 2019 Class II Zantac® 06671597362, 06671597363,60671597368, 00597012201 00597012208, 00597012213 00597012237, 00597012240 00597012254, 00597012261 00597012281, 00597012296 Presence of impurities If you have questions about this recall, Sanofi- Aventis U.S. LLC, 1- 800- 633-1610 December 2019 Class II Regular Strength Zantac® 05026922225, 06775115101, 06775115201, 06775115202, 06815125840 Presence of impurities If you have questions about this recall, Sanofi- Aventis U.S. LLC, 1- 800- 633-1610 December 2019 Class II
Maximum Strength Zantac® 00597012101, 00597012106, 00597012108, 00597012109, 00597012111, 00597012124, 00597012138, 00597012150, 00597012164, 00597012166, 00597012168, 00059701218, 00597012180, 00597012182, 00597012185, 00597012190, 0059701294 Presence of impurities If you have questions about this recall, Sanofi- Aventis U.S. LLC, 1- 800- 633-1610 December 2019 Class II Regular Strength Zantac® 04116703000, 04116703001, 04116703003, 04116703005, 04116703006, 04116703007, 04116703008,00526922025 Presence of impurities If you have questions about this recall, Sanofi- Aventis U.S. LLC, 1- 800- 633-1610 December 2019 Class II Cool Mint Tablets Maximum Strength Zantac® 00597012006,00597012008, 00597012009,00597012024, 00597012038,00597012050, 00597012076, 00597012078 00597012080,00597012082, 00597012087, 04116703201, 04116703202, 04116703203 04116703204,04116703205 04116703206, 04116703207 Presence of impurities If you have questions about this recall, Sanofi- Aventis U.S. LLC, 1- 800- 633-1610 December 2019 Class II
Ibuprofen 068788726801 Presence of foreign substance If you have questions about this recall, Preferred Pharmaceuticals Inc 1- 714-777-3729 December 2019 Class II Lidocaine hcl 05515016505 Presence of foreign substance If you have questions about this recall, AuroMedics Pharma, 1- 888-238-7880 December 2019 Class II Ranitidine 04229172460, 04229172530, Presence of impurities If you have questions about this recall, AvKARE, Inc, 1-931-292-6222 December 2019 Class II Ranitidine 06516225306, 06516225310, 06516225318, 06516225350, 06516225311, 06516225430, 06516225410, 06516225425, 06516266490, 05374625310, 05374625402 Presence of impurities If you have questions about this recall, Amneal Pharmaceuticals, Inc., 1- 908-947-3120 December 2019 Class II Ranitidine 068788707803, 068788707806 Presence of impurities If you have questions about this recall, Preferred Pharmaceuticals Inc 1- 714-777-3729 December 2019 Class II
Ranitidine 05591009279 Presence of impurities If you have questions about this recall, Dolgencorp LLC, Inc, 1- 615-855-4000 December 2019 Class II Ranitidine 05965114460, 059651145-30, 06586243174, 05965114405, Presence of impurities If you have questions about this recall, Aurobindo Pharma, 1-866- 850-2876 December 2019 Class II Walgreens Sodium Chloride Ophthalmic Solution 00363019313 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Walgreens Sodium Chloride Ophthalmic Ointment 00363750050 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Walgreen’s Lubricant Eye Ointment, Mineral Oil 00363019150 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Equate Support Harmony Lubricant Eye Drops 04903514510 Lack of Assurance of Sterility If you have questions about this recall, Altaire November 2019 Class II
Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 Equate Support Advanced 04903588549 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Equate Support Advanced Lubricating Eye Drops 04903588254 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Equate Support Advanced Lubricant Gel Drops 0903588252 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Equate Sterile Lubricant Stye Ointment 04903587550 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Equate Restore Tears Lubricant Eye Drops Twin Pack 04903518949 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II
Equate Restore PM Nighttime Lubricant Eye Ointment 04903519150 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Equate Night & Day Restore Tears Lubricant Eye Pack 04903588359 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Equate Eye Allergy Relief Drops 4903587413 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Equate Eye Allergy Relief Drops 04903588713 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Equate Comfort Gel Lubricant Eye Gel 04903519749 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Puralube Petrolatum Ophthalmic Ointment® 00574402535 Lack of Assurance of Sterility If you have questions about this recall, Altaire November 2019 Class II
Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment® 00574402135 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution® 05479950215 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II CVS Health Preservative Free Lubricant Eye Drops® 50428302958 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II TRP Stye Relief® 01731201413 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II TRP Pink Eye Relief® 01731201315 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II
TRP Blur Relief 01731200211 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Perrigo Sulfacetamide Sodium Ophthalmic Ointment® 00574419035 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic® 00574414435 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment® 0574425035 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic® 0574416035 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II
Perrigo Bacitracin Ophthalmic Ointment® 0574402235 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Ofloxacin Ophthalmic Solution 05939014005 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic® 05479950505 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic 05479950501® Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic® 05479950405 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic® Lack of Assurance of Sterility If you have questions about this recall, Altaire November 2019 Class II
05479950401 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 OCuSOFT Tears Again Sterile Lubricant Eye Drops® 05479990430 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Ocusoft Tears Again Lubricant Eye Drops ® 05479990415 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II OCuSOFT Homatropine Hydrobromide Ophthalmic Solution® 05479943105 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution® 05479950315 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution® 05479950721 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II
OCuSOFT Eye Wash Sterile Isotonic Buffered Solution® 05479956501 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II OCuSOFT Eye Wash Sterile Isotonic 05479956559 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Natural Ophthalmics Women’s Tear Stimulation Dry Eye Drops® 06877010315 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops® 06877010415 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Natural Ophthalmics Ortho-K Thin Eye Drops® 06877014415 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Natural Ophthalmics Ortho-K Thick Comfort Gel 06877014315 Lack of Assurance of Sterility If you have questions about this recall, Altaire November 2019 Class II
Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 Natural Ophthalmics Cataract Eye Drops® 06877013015 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Natural Ophthalmics Allergy Desensitization Eye Drops® 06877012015 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Nano Tears XP Clear Emollient Lubricant Gel Drops® 05939014351 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Nano Tears TF Clear Emollient Lubricant Gel Drops® 05939014249 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Nano Tears TF Clear Emollient Lubricant Gel Drops® 05939014156 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II
Lubricant Eye Drops Moisturizing Twin Pack® 00363018549 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II iSolutions NanoTears HA Preservative Free Multi – Dose Lubricant Gel Drops® 05939020810 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops® 05939014310 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops® 05939014213 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops® 05939014152 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops® Lack of Assurance of Sterility If you have questions about this recall, Altaire November 2019 Class II
05939014756 Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops® 05939014410 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II iSolutions Nano Tears MO Clear Emollient Lubricant Drops® 05939014510 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II iSolutions ActivEyes Nighttime Lubricant Eye Ointment® 05939019050 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II FreshKote Lubricant Eye Drops® 01582110115 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Altaire Sterile Eye Wash® 05939017513, 05939017535, 05939017518 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II
Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution® 05939019205 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution® 05939018213 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution 05939020505® Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Altaire Diclofenac Sodium Opthalmic Solution® 5939014905 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Altaire Diclofenac Sodium Opthalmic Solution® 05939014902 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Altaire Ciprofloxacin Ophthalmic Solution® 05939021710 Lack of Assurance of Sterility If you have questions about this recall, Altaire November 2019 Class II
Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 Altaire Ciprofloxacin Ophthalmic Solution® 05939021702 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Altaire Ciprofloxacin HCl Ophthalmic Solution® 05939021705 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution ® 05939018113 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II ActivEyes Sterile Altalube Ointment® 05939019850 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops® 05939014852 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II
ActivEyes Preservative Free Multi-Dose Lubricant Drops® 05939014652 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II ActivEyes Sterile Altalube Ointment® 05939019850 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops® 05939014852 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II ActivEyes Preservative Free Multi-Dose Lubricant Drops® 05939014652 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II ActivEyes Lubricant Eye Ointment® 05939018950 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II ActivEyes Altachlore Solution 05939018313® Lack of Assurance of Sterility If you have questions about this recall, Altaire November 2019 Class II
Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 ActivEyes Altachlore Sodium Chloride Hypertonicity Opthalmic Ointment® 05939018450 Lack of Assurance of Sterility If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16 November 2019 Class II Ranitidine 05140709705 impurity detected If you have questions about this recall, Golden State Medical Supply Inc. 1-805-477-9866 November 2019 Class II Novitium Pharma Ranitidine® 07095400120 07095400140 07095400210 07095400240 impurity detected If you have questions about this recall, Novitium Pharma LLC. 1-855-204- 1431 November 2019 Class II Rite Aid Pharmacy Maximum Strength Ranitidine ® 01182260522 01182260518 Possible contamination If you have questions about this recall, Apotex Inc. 1-800-706-5575 November 2019 Class II Equate Maximum Strength Ranitidine® 04903511706 Possible contamination If you have questions about this recall, Apotex Inc. 1-800-706-5575 November 2019 Class II
Rite Aid Pharmacy Maximum Strength Ranitidine® 01182261074 Possible contamination If you have questions about this recall, Apotex Inc. 1-800-706-5575 November 2019 Class II Equate Maximum Strength Ranitidine® 04903510007 04903510000 Possible contamination If you have questions about this recall, Apotex Inc. 1-800-706-5575 November 2019 Class II Walgreens Regular Strength Wal-Zan 75 Ranitidine® 00363102903 Possible contamination If you have questions about this recall, Apotex Inc. 1-800-706-5575 November 2019 Class II Walgreens Maximum Strength Wal-Zan 150 Ranitidine® 00363103007 00363103006 Possible contamination If you have questions about this recall, Apotex Inc. 1-800-706-5575 November 2019 Class II Alprazolam tablets 00378400305 Presence of foreign substance If you have questions about this recall, Mylan Pharmaceuticals. 1-304- 599-2595 November 2019 Class II Ranitidine tablets 00363001061 ,00363001062 ,00363001001, 04903540461, 04903540413,04903540465, 03014250534, 03014250550, 00150062076, 06984287130, 06984287180,06984287137, Impurity detected in product. If you have questions about this recall, Dr. Reddy’s Laboratories, Inc. 1-309-375-9900 November 2019 Class II
03014213130, 06386848230, 06386848260, 04359880862 04359880865, 07171320302 07171320305, 05789671524, 01167384940, 05511113160, 05511140434, 00363013130 00363013180, 06386848024 06386848050, 05789671705 Ranitidine capsules 05511112960, 05511112905, 05511113030, 05511113001 Impurity detected in product. If you have questions about this recall, Dr. Reddy’s Laboratories, Inc. 1-309-375-9900 November 2019 Class II Atorvastatin calcium 06050525808 Presence of foreign substance If you have questions about this recall, Apotex, Inc. 1-800-706-5575 November 2019 Class II Gatifloxacin Ophthalmic Solution® 06131467225 Labeling error If you have questions about this recall, Sandoz, Inc. 1-609-627-8500 November 2019 Class II Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension 06131463006 Incorrect or missing package insert If you have questions about this recall, Sandoz, Inc. 1-609-627-8500 November 2019 Class II
Bimatoprost Ophthalmic Solution 00781620675 Incorrect or missing package insert If you have questions about this recall, Sandoz, Inc. 1-609-627-8500 November 2019 Class II Testosterone Cypionate Injection 05253662501 Labeling error If you have questions about this recall, Arbor Pharmaceuticals. 1-866- 284-8792 November 2019 Class II Ranitidine tablets 05591009279 Empty bottles If you have questions about this recall, AuroMedeics Pharma LLC. November 2019 Class II Ranitidine hydrochloride capsules 04229173550,04229173650 Impurities If you have questions about this recall, AvKare, Inc. 1-931-292-6222 November 2019 Class II Estradiol vaginal inserts 06846271188 Impurities If you have questions about this recall, Glenmark Pharmaceuticals. 1-888- 721-7115 November 2019 Class II Prasugrel tablets® 00378518593 Failed dissolution specification If you have questions about this recall, Mylan Pharmaceuticals. 1-304- 599-2595 November 2019 Class II
Ibuprofen suspension 05167213858,05167221308, 51672138509,05167221301, 6709132104 Presence of foreign substance If you have questions about this recall, Taro Pharmaceuticals. 1-866- 923-4914 November 2019 Class II Leucovorin Calcium 05074246450 Presence of particulate matter If you have questions about this recall, Ingenus Pharmaceutical. 1-877- 748-1970 October 2019 Class II Pioglitazone Hydrochloride 03334205407 Superpotent If you have questions about this recall, Macleods Pharmaceuticals Ltd, 91- 22-6676-2800 October 2019 Class II Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 01310707301 Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness. If you have questions about this recall, Aurobindo Pharma USA Inc. 1-732-839-9400 October 2019 Class II Fentanyl Citrate® 49452003206 Potential contamination If you have questions about this recall, Spectrum Laboratory Products. 1- 800-772-8786 October 2019 Class II Ascorbic Acid 07159150050 Labeling issue If you have questions about this recall, Atlas October 2019 Class II
Pharmaceutical. 1-410- 860-8500 Pantoprazole Sodium Delayed Release 05974628490 Discoloration on edges of tablets If you have questions about this recall, Jubilant Cadista Pharmaceuticals, Inc. 1-410-860-8500 October 2019 Class II Vivitrol® 65757030001 Mislabeling If you have questions about this recall, Alkermes, Inc. 1-800-848-4876 September 2019 Class II Relpax® 00049234005, 00049234045 Microbial contamination If you have questions about this recall, Pfizer Inc1-877-225-9750 September 2019 Class II Hydrocortisone cream with aloe, Hydrocortisone 00363062003, 00363062004 Potential microbial contamination If you have questions about this recall, US Pharmaceuticals Inc. 1- 888-337-7464 August 2019 Class II Lisinopril and hydrochlorothiazide tablets 68180051801, 68180051802 Brownish/blackish stains on the tablets If you have questions about this recall, Lupin Limited 1-866-587-4617 August 2019 Class II
Nitrofurantoin monohydrate/macrocrystals capsules 47781030301 Failed dissolution specifications If you have questions about this recall, Alvogen, Inc. 1-866-770-3024 August 2019 Class II Macrobid Urinary Tract Antibacterial 52427028501 Failed dissolution specifications If you have questions about this recall, Alvogen, Inc. 1-866-770-3024 August 2019 Class II Aspirin and extended-release dipyridamole capsules 60687030532 Failed impurities/degradation specifications If you have questions about this recall, American Health Packaging 1-614- 492-8177 August 2019 Class II Doxycycline hyclate 62584069321 Failed dissolution specifications If you have questions about this recall, American Health Packaging August 2019 Class II Neomycin 3.5 mg/g / polymyxin b10000 usp units/g / dexamethasone 1 mg/g ophthalmic ointment 52959040701 Insufficient quality If you have questions about this recall, H.J. Harkins Company 1-805- 929-1333 July 2019 Class II Diphenhydramine 49035033002, 49035033096, 49035033045 Contamination If you have questions about this recall, LNK International 1-631-543- 3787 July 2019 Class II
Norethindrone and ethinyl estradiol 68180090313 Failed Impurities If you have questions about this recall, Lupin Pharmaceuticals 1-800- 399-2561 July 2019 Class II Milrinone lactate 00409277602, 00409277623 Bags have the potential to leak If you have questions about this recall, Pfizer Inc. 1-800-879-3477 July 2019 Class II Fluorouracil injection 63323011710, 63323011719, 63323011728, 63323011761, 63323011761, 63323011769, 63323011718, 63323011720, 63323011751, 63323011759, 63323011768 Glass Particles If you have questions about this recall, Fresenius Kabi 1-888-386-1300 June 2019 Class I Heparin Sodium® 00264958720 Not potent If you have questions about this recall, Braun Medical Inc 1-800-523- 9676 June 2019 Class II Estradiol vaginal inserts 68462071171, 68462071188 Defective delivery If you have questions about this recall, Glenmark Pharmaceuticals Inc 1-201-684-8000 June 2019 Class II
Zyflo Cr® 10122090212, 10122090220 Failed dissolution If you have questions about this recall, Chiesi USA, 1-919-678-6611 June 2019 Class II Pramipexole dihydrochloride 68084079325, 68084097425 Possible cross contamination If you have questions about this recall, American Health Packaging, 1-800- 707-4621 May 2019 Class II Zileuton® 66993048532 Failed dissolution If you have questions about this recall, Chiesi USA, 1-919-678-6611 May 2019 Class II Testosterone 69699170230, 69699170210 Lack of sterility If you have questions about this recall, Pharm D. Solutions 1-713-790-1693 May 2019 Class II Hydrocodone bitartrate and homatropine methylbromide oral solution 59741026216, 13668057710 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Risperidone 23155031751 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II
Cetirizine hydrochloride 23155029251, 23155029252, 13668059607, 13668059611 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Phenylephrine hydrochloride 00536138912, 00536138935, 00904768822 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Bisacodyl 00536135501, 00536135512 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Hydrocortisone acetate suppositories 59741030101, 59741030124, 59741030112 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Memantine hydrochloride 39328055112 13668057309 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Lactulose solution Contamination with burkholderia If you have questions about this recall, Torrent May 2019 Class II
13668058008, 13668058012, 13668057408, 13668057412, 13668057410 Pharma Inc 1-800-912- 9561 Pseudoephedrine Hydrochloride 00536185085, 00536185097 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Diphenhydramine hydrochloride 00536077085, 00536077097 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Guaifenesin & dextromethorphan hydrobromide 00536097085, 00536097097 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Guaifenesin 00536082585, 00536082597 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Acetaminophen 00536012285, 00536012297 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II
Phenobarbital 16571033016 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Guaifenesin, Codeine Phosphate & Pseudoephedrine Hydrochloride 16571030116 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Guaifenesin AC 16571030216 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Acetic Acid 64980042415 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Hyoscyamine sulfate 39328004715, 39328004816 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Cyproheptadine hydrochloride 39328004416 Contamination with burkholderia If you have questions about this recall, Torrent May 2019 Class II
Pharma Inc 1-800-912- 9561 Bisacodyl 00904505812, 00904505860 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Pedia Relief 00904505020 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Robafen dm cough sugar free clear 00904630620 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Oxymetazoline Hydrochloride 00904571130, 00904571135 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Pseudoephedrine hydrochloride 00536185085, 00536185097 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II
Banofen 904517416 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Robafen DM 00904005300, 00904005316 00904005309 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Robafen AC 00904647916 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Risperidone 13668058906 Contamination with burkholderia If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561 May 2019 Class II Pecgen dmx 52083063016 Incorrect labeling instructions If you have questions about this recall, Novis PR 1-800-727-6711 May 2019 Class I Cefdinir for oral suspension 68180072310, 68180072320 Metal piece identified in the product bottle If you have questions about this recall, Lupin May 2019 Class II
Pharmaceuticals Inc 1- 410-576-2000 Articaine Hydrochloride and Epinephrine Bitartrate® 66312060116 Mislabeling If you have questions about this recall, Septodont Inc 1-717-286- 0100 May 2019 Class II Losartan Potassium tablets 23155064503, 23155064509, 23155064510, 23155064603, 23155064610, 23155064609, 23155064403, 23155064410, 23155064409 Presence of an impurity If you have questions about this recall, Heritage Pharmaceuticals Inc 1- 866-901-DRUG (3784) May 2019 Class II Amitiza® 64764008060, 64764024010, 64764024060 24 mcg capsules were found in a 8 mcg If you have questions about this recall, Mallinckrodt Pharmaceuticals 1-314- 654-2000 May 2019 Class II Losartan Potassium tablets 60429031610, 60429031690, 60429031630, 60429031810, 60429031890, 60429031830 Presence of an impurity If you have questions about this recall, Golden State Medical Supply Inc 1-800-284-8633 ext. 215 May 2019 Class II Divalproex sodium 00904636345, 00904636361 Exposed above 50% relative humidity levels If you have questions about this recall, Major April 2019 Class II
Pharmaceuticals 1-800- 875-0123 option 5 Losartan Potassium tab 68788004809 Presence of an impurity If you have questions about this recall, Preferred Pharmaceuticals Inc 1- 714-777-3729 April 2019 Class II Carvedilol tablets 65841061605 Label Mix-up If you have questions about this recall, Zydus Pharmaceuticals 1-877- 993-8779 April 2019 Class II Ketorolac tromethamine 25021070101, 25021070102 Lack of sterility If you have questions about this recall, Sagent Pharmaceuticals 1-866- 625-1618 April 2019 Class II Acyclovir tablets 68382079101, 68382079106, 68382079116, 68382079105, 68382079110, 68382079130 Label mix-up If you have questions about this recall, Zydus Pharmaceuticals 1-877- 993-8779 April 2019 Class II Fentanyl transdermal system, 12 mcg/h 47781042347 Label mix-up If you have questions about this recall, Alvogen 1-866-770-3024 April 2019 Class I
Losartan Potassium/hctz 70518156000 Presence of an impurity If you have questions about this recall, Remedy Repack 1-866-845-3791 April 2019 Class II Losartan Potassium and hydrochlorothiazide tablets 13668011610, 13668011674, 13668011630, 13668011690, 13668011710, 13668011774, 13668011730, 13668011790, 13668011810, 13668011874, 13668011830, 13668011890 Presence of an impurity If you have questions about this recall, Torrent Pharmaceuticals 1-800- 912-9561 April 2019 Class II Losartan Potassium 68645049454 Presence of an impurity If you have questions about this recall, Legacy Pharmaceutical Packaging LLC 1-314-813-1555 April 2019 Class II Losartan Potassium 50268051715, 50268051615 Presence of an impurity If you have questions about this recall, Avkare Inc 1-931-292-6222 April 2019 Class !! Losartan Potassium 13668011310, 13668011390, 13668011374, 13668040990, 13668040930, 13668040910, 13668040974, 13668011510, 13668011574, 13668011530, 13668011590 Presence of an impurity If you have questions about this recall, Torrent Pharmaceuticals 1-800- 912-9561 April 2019 Class II
Gavilyte- N 43386-0050-19 Labeling incorrectly classified If you have questions about this recall, Lupin Pharmaceuticals 1-800- 399-2561 March 2019 Class II Combigan 00023921103, 00023921110, 00023921105, 00023921115 Trace amounts of an impurity If you have questions about this recall, Ecolab 1- 800-433-8871 March 2019 Class II Pravastatin Sodium 68462-0196-05, 68462-0196-90 Foreign tablet in bottle If you have questions about this recall, Glenmark Pharmaceuticals, Inc. 201- 684-8000 March 2019 Class II Losartan 70518-0588-01 Trace amounts of impurity If you have questions about this recall, Remedy repack Inc 1-886-845- 3791 March 2019 Class II Phenobarbital 70166-0536-02 The label contains the incorrect expiration date If you have questions about this recall, Lohxa LLC 1-800-641-5564 March 2019 Class II
Losartan Potassium 31722-0702-30 Impurity found If you have questions about this recall, Pharma Pac 1-805-929-1333 March 2019 Class II Volumex 50914-7720-08 Lack of assurance If you have questions about this recall, Iso-Tex Diagnostics 1-800-477- 4539 March 2019 Class II Hydrocortisone and Acetic Acid 50383-0301-10 Sub Potent Drug If you have questions about this recall, call Akon Inc. 1-800-477-4539 March 2019 Class II Losartan Potassium 68645-0578-54 Trace amounts of impurity If you have questions about this recall, Call Legacy 1-877-538-8443 February 2019 Class II Losartan Potassium/Hydrochlorothiazide 13668-0118-10, 13668-0118-74, 13668-0118-30,13668-0118-90, 13668-0117-10, 13668-0117-74, 13668-0117-30, 13668-0117-90, 13668-0116-10, 13668-0116-74, 13668-0116-30, 13668-0116-90 Presence of Impurity If you have questions about this recall, Call Torrent Pharmaceuticals 1-800-912-9561 February 2019 Class II Losartan Potassium 13668-0113-10, 13668-0113-90, 13668-0113-74 13668-0409-10 Presence of an impurity If you have questions about this recall, Call February 2019 Class II
13668-0409-74, 13668-0409-30, 13668-0409-90, 13668-0115-10, 13668-0115-74, 13668-0115-30, 13668-0115-90 Torrent Pharmaceuticals 1-800-912-9561 Valsartan 52343-0122-30, 52343-0123-90, 52343-0124-90, 52343-0125-90 Presence of an impurity If you have questions about this recall, Call Preferred Pharmaceuticals 1-855-544-9419 February 2019 Class II Losartan Potassium 68788-6882-03, 68788-6882-09 Presence of an impurity If you have questions about this recall, Call Preferred Pharmaceuticals 1-855-544-9419 February 2019 Class II Valsartan 60687-0139-01 Trace amounts of an impurity If you have questions about this recall, call Aurobindo 1-800-912- 9572 February 2019 Class II Losartan Potassium 31722-0702-05, 31722-0702-30, 31722-0702-90, 31722-0702-10, 31722-0702-60, 50268-0517-15, 50268-0513-15, 50268-0514-15, 68645-0577-54 Trace amounts of an impurity If you have questions about this recall, call Aurobindo 1-800-912- 9572 February 2019 Class II
Alprazolam 51079-0788-20 Failed impurities/degradation If you have questions about this recall, call Mylan 1-888-406-9305 January 2019 Class II Ceftriaxone for Injection 68180-0611-01 Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials If you have questions about this recall, Lupin Pharmaceuticals Inc. 111 S Calvert St Fl 21ST Baltimore, MD 21202-6174 January 2019 Class I Vecuronium Bromide for Injection 10 mg 47335-0931-44 Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection. If you have questions about this recall, Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Rd Cranbury, NJ 08512-3605 January 2019 Class I OZURDEX 0023-3348-07 Deviations: A silicone particulate was noted in Ozurdex If you have questions about this recall, Allergan, PLC. 5 Giralda Farms Madison, NJ 07940-1027 (714) 246-4500 January 2019 Class II Estradiol Vaginal Inserts 68462- 711-71 68462-711-88 Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator If you have questions about this recall, Glenmark Pharmaceuticals Inc., USA January 2019 Class II
750 Corporate Dr Mahwah, NJ 07430-2009 Dianeal Low Calcium 00941-0424-52 Lot #: Y281477 Expiration: 02/2020 Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing If you have questions about this recall, Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625 January 2019 Class II Cefdinir for Oral Suspension USP 125mg/5mL 68180-0722-10 68180-0722-20 Deviations: Product complaints received indicating reconstituted suspension was observed to be thick If you have questions about this recall, Lupin Pharmaceuticals Inc. 111 S Calvert St Fl 21ST Baltimore, MD 21202- 6174 866-587-4617 January 2019 Class II Cidofovir Injection 375mg 23255-0216-31 Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle If you have questions about this recall, Heritage Pharmaceuticals, Inc. 1 Tower Center Blvd Ste 1700 East Brunswick, NJ 08816-1145 732) 429-1000 January 2019 Class II Cephalexin for Oral Suspension USP 68180-0124-01 Deviation; manufacturing batch record could not be located If you have questions about this recall, Lupin Pharmaceuticals Inc. January 2019 Class II
68180-0124-02 111 S Calvert St Fl 21ST Baltimore, MD 21202 866-587-4617 Valsartan tablets USP 320 mg 65862-0573-05 65862-0573-90 Deviations: FDA lab confirmed presence an impurity, N- nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. If you have questions about this recall, Aurobindo Pharma USA Inc. 279 Princeton Hightstown Rd East Windsor, NJ 08520- 1401 732-839-9400 January 2019 Class II Valsartan and Hydrochlorothiazide tablets 65862-0549-10 65862-0549-90 65862-0549-99 Deviations: FDA lab confirmed presence an impurity, N- nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million If you have questions about this recall, Aurobindo Pharma USA Inc. 279 Princeton Hightstown Rd East Windsor, NJ 08520 732- 839-9400 January 2019 Class II Amlodipine and Valsartan Tablets USP 10 mg/320 mg Deviations: FDA lab confirmed presence an impurity N- If you have questions about this recall January 2019 Class II
65862-0740-03 65862-0740-30 65862-0740-90 nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million. Aurobindo Pharma USA Inc. 279 Princeton Hightstown Rd East Windsor, NJ 08520- 1401 732 839 9400 EEMT (esterified estrogens and methyltestosterone 15310-0010-01 The combination of esterified estrogens and methyltestosterone is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. If you have questions about this recall, Syntho Pharmaceuticals, Inc. 230 Sherwood Ave Farmingdale, NY 11735- 1718 631-755-9898 January 2019 Class II Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg 00093761756 00093761798 Failed dissolution specifications If you have questions about this recall, Teva Pharmaceuticals USA 1090 Horsham Rd North Wales, PA 19454- 1505 888-TEVA-USA (888-838- 2872) January 2019 Class II
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle Lot #: S700214, Exp Apr-19; S700447, Exp Jun-19; S700787, Exp Oct-19; S701057, Exp Nov- 19; S800107, Exp Feb-20; S800266, Exp Mar-20; S800524, Exp May-20; S800791 Kul Exp Jul-20 Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient If you have questions about this recall, Contact: LUPIN SOMERSET 400 Campus Dr Somerset, NJ 08873-1145 January 2019 Class II Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles Lot #: 43E021 and 43E023, Exp. 01/2020 Presence of Foreign Substance: Product complaint of black speckles observed on tablets. If you have questions about this recall, Contact: Dr. Reddy’s Laboratories, Inc. 107 College Rd E Princeton, NJ 08540-6623 January 2019 Class II Losartan potassium and hydrochlorothiazide 1000mg/25mg tablets ONLY Lot: JB8912 This product is being recalled due to th presence of an impurity, N- nitrosodiethylamine. NDEA occurs naturally in manufacturing processes and could cause cancer based on laboratory test results. No adverse effects related to this recall have been reported to date. If you have questions about this recall, Contact Sandoz Inc. at 1-800-525- 8747 Monday-Friday 8:30 AM – 5:00 PM (EST) or email usdrugsafety.operations@ novartis.com. November 2018 Class I
Montelukast Sodium 10Mg This medicine is made by Camber Pharmaceuticals, Inc. This medicine is being recalled because sealed bottles labeled as Montelukast sodium tablets, 10 mg, 30-count bottle from Camber were found to instead contain 90 tablets of losartan potassium tablets, 50 mg. This could result in a life-threatening condition. If you have questions about this recall, call Camber Pharmaceuticals Med Line at 1-866-495- 1995 September 2018 Class I Diphenoxylate Hydrochloride and Atropine Sulfate tablets, 2.5 mg/0.025 mg (Lomotil). This medication is made by Greenstone LLC, a wholly owned subsidiary of Pfizer, Inc. This medication is being recalled due to super potency. The use of the impacted super potent product when used as labeled has a low probability of being associated with adverse events of limited severity such as lethargy, skin flush, and drowsiness. Serious adverse events such as coma and respiratory depression are improbable. If you have questions about this recall, please contact Pfizer Customer Support at 800-879-3477. January 2018 Class I
EpiPen and EpiPen Jr Auto- Injector This medication is made by Mylan. This medication is being recalled due to failure to activate the device or increased force needed to activate due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency. This could result in a life-threatening condition. If you have questions about this recall, please contact your physician, pharmacy or Mylan Customer Relations at 800-796-9526 or customer.service@mylan. com. May 2017 Class I
<
