Cipla US, a subsidiary of the pharmaceutical company Cipla, is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol. The affected batches were manufactured in November 2021 and are being recalled due to a device defect that may result in a failure to deliver the recommended dose of medication.
The recall is being initiated in the United States following a market complaint for one inhaler (Batch Number – IB20056) where leakage was observed through the inhaler valve. As a precautionary measure, Cipla is recalling the six batches manufactured using the same lot of valves.
|Sr. No.||Product Name||Batch No.||Expiry Date|
|1.||Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI)||IB20045||Nov.2023|
|2.||Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI)||IB20055||Nov.2023|
|3.||Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI)||IB20056||Nov.2023|
|4.||Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI)||IB20057||Nov.2023|
|5.||Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI)||IB20059||Nov.2023|
|6.||Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI)||IB20072||Nov.2023|
The recalled product, Albuterol Sulfate Inhalation Aerosol, is used for the treatment and prevention of bronchospasm in individuals with reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm. The product is packaged in a 17ml plain aluminium aerosol canister with a dose counter, plastic actuator, and dust cap. Each pack claims 200 metered inhalations.
These six batches were distributed nationwide to wholesalers and retailers. Cipla is notifying its distributors and customers by letter and arranging for the return and replacement of all recalled products. Consumers, distributors, and retailers in possession of the affected batches are advised to stop using them and either return them to the place of purchase or discard them.
No adverse events related to these specific batches of Albuterol Sulfate Inhalation Aerosol have been reported thus far. However, there is a reasonable probability that failure to deliver the recommended dose due to the device defect may be life-threatening, particularly for individuals experiencing acute asthma exacerbations.
Consumers with questions or concerns about the recalled batches can contact Cipla Customer Service at 844-CIPLAUS (844-247-5287) Monday through Friday, 8:30 AM to 5:00 PM EST, or via email at firstname.lastname@example.org. Any adverse reactions or quality problems experienced with the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program.
Cipla emphasizes its commitment to stringent quality processes and the safety of its products. The company conducts regular investigations and assessments with the involvement of subject-matter experts, quality management, and medical safety experts. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.