Cipla Recalls 6 Albuterol Sulfate Aerosol Batches

FDA says Cipla US has recalled six batches of albuterol sulfate inhalation aerosol, 90 mcg (200 metered inhalation) due to a container defect that could result in a failure to deliver the recommended dose. An agency statement says the six batches were manufactured in 11/2021.

The statement says Cipla found “there is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of an acute asthma exacerbation such as wheezing, coughing, shortness of breath, and bronchospasms, due to device defect, may be life-threatening.” It says there have been no adverse events reported for the inhaler related to the recall. Cipla says it ordered the recall in the U.S. due to a market complaint about one inhaler in which leakage was observed through the inhaler valve. “Out of an abundance of caution,” the company says, “the six batches manufactured using the same lot of valves are being recalled.”