Empty Inhaler Prompts Bronchodilator Recalled

Cipla is recalling 278,538 canisters of albuterol sulfate inhalation aerosol due to a market report of an empty inhaler and leakage observed through the inhaler valve, according to the July 19, 2023, US Food and Drug Administration (FDA) Enforcement Report. 

Although the report involved a single inhaler, Cipla said in a July 6, 2023, announcement that it was recalling a total of 6 batches manufactured using the same lot of valves “out of an abundance of precaution.”

The recall affects albuterol sulfate inhalation aerosol, 90 mcg, 200 metered inhalation, net content 6.7 g canister packaged in a box (NDC 69097-142-60), from lots IB20045, IB20055, IB20056, IB20057, IB20059, and IB20072 (Exp 11/23). The products were manufactured by Cipla Ltd, Pithampur, India, for Cipla USA Inc, Warren, New Jersey, and were distributed throughout the United States.

Cipla voluntarily initiated the recall June 27, 2023. The FDA has not yet issued a recall classification. 

Albuterol sulfate inhalation aerosol is used for the treatment and prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

“There is a 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,” Cipla stated in the announcement. “There were no adverse events reported for albuterol sulfate inhalation aerosol 90 mcg related to this recall.”