Cipla recalls six batches of inhalers due to container defect!

Cipla Limited, a leading pharmaceutical company, has made an official announcement regarding a voluntary recall of six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) produced in November 2021. The recall, conducted in collaboration with the U.S. Food and Drug Administration, pertains to ensuring consumer safety and product quality at the highest standards. 

Risk Advisory: It is of significant concern that the failure to administer the prescribed dosage of Albuterol Sulfate Inhalation Aerosol, 90 mcg, due to a device defect, may pose a potential life-threatening risk for patients suffering from acute asthma exacerbations. The recall is a precautionary measure undertaken by Cipla Limited, prompted by a market complaint regarding a single inhaler (Batch Number – IB20056) that exhibited leakage through the inhaler valve. 

As a result, in an abundance of caution, six batches manufactured using the same batch of valves are being voluntarily recalled to mitigate any potential risks. It is important to note that no adverse events have been reported thus far for Albuterol Sulfate Inhalation Aerosol 90 mcg associated with this recall. 

The recalled product, Albuterol Sulfate Inhalation Aerosol, is primarily intended for the treatment and prevention of bronchospasm in individuals with reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm. It is packaged in a 17 ml aerosol canister made of plain aluminium, featuring a dose counter for convenient tracking. The canister is equipped with a plastic actuator and dust cap. Each pack is labelled to contain 200 metered inhalations and is identified by the associated codes NDC-69097-142-60. 

The six batches of the recalled Albuterol Sulfate Inhalation Aerosol were distributed across the United States to various wholesalers and retailers. Cipla is taking proactive measures by sending notifications to its distributors and customers via letter, outlining the recall details. The company is coordinating the return and replacement process for all the recalled products. 

Consumers, distributors, and retailers in possession of products from these specific batches are advised to cease using them immediately and either return them to the place of purchase or dispose of them appropriately.