Cipla recalls six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 MI) due to container defect

Cipla announced that its wholly-owned subsidiary, Cipla USA Inc, is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer level.

In a statement, the company said, “There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of acute asthma exacerbations such as wheezing coughing, shortness of breath and bronchospasms, due to device defect, may be life-threatening. There were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall. The company is initiating a recall in the US due to a market complaint for one single inhaler (Batch Number – IB20056), where leakage was observed through the inhaler valve. Out of an abundance of precaution, of the above mentioned six batches manufactured using the same lot of valves are being recalled.”

The product is used for the treatment and prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise induced bronchospasm. The product is packaged in 17ml plain aluminium aerosol canister integrated with dose counter coupled with plastic actuator and dust cap, each pack claims 200 metered inhalations and associated codes NDC-69097-142- 60. These six batches were distributed Nationwide to wholesalers and retailers. Cipla is notifying its distributors and customers by letter and is arranging for return and replacement of all recalled products. Consumers/distributors/retailers that have product from these six batches which are being recalled should stop using/return to place of purchase/discard.

This recall is being conducted with the knowledge of the US Food and Drug Administration.