AUDIENCE: Consumer, Health Professional, Ophthalmology
ISSUE: Kilitch Healthcare India Limited is recalling the eye drops products with all lots within expiry with expiration dates ranging from November 2023 to September 2025. These products are being recalled due to potential safety concerns after FDA investigators found insanitary conditions.
Risk Statement: For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.
To date, Kilitch Healthcare India Limited has not received any reports of adverse events related to this recall.
These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC.
For more information about this recall, click on the red button “Read Recall” below.
BACKGROUND: The products being recalled are sold as eye drops and are intended to be sterile.
• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
• Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product.
• Consumers should stop using the recalled eye drops and may return them to the place of purchase.
• Consumers with questions regarding this recall can contact the company.
Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.