Cipla issues albuterol recall

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Cipla U.S., a subsidiary of Cipla Limited, has issued a voluntary recall of six batches of albuterol sulfate inhalation aerosol, 90 mcg (200 metered inhalation) manufactured in November 2021 to consumers.

According to company spokespeople, there is “reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of an 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. Doctors should remind patients to check the batch number on their inhaler.

The company pointed to a problem with the inhaler valve in those six batches. 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 recalled product is packaged in a 17ml plain, aluminum aerosol canister integrated with a dose counter and coupled with a plastic actuator and dust cap. Each pack claims 200 metered inhalations and is 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. Doctors should remind patients to stop using or return the product to place of purchase or discard.

If your patients are looking for more information, direct them to Cipla Customer Service at 844-CIPLAUS (844-247-5287) or by email at [email protected].

Adverse reactions or quality problems experienced with the use of this product can be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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