Indian pharmaceutical company Cipla’s fully-owned subsidiary in the U.S., Cipla USA Inc., issued a nationwide recall of six batches of albuterol sulfate inhalation aerosol due to a container defect. The recalled products were manufactured in November 2021 and had a shelf life of two years.
The recall was initiated in the U.S. after a market complaint for a single inhaler that had a leakage in the inhaler valve. The defect was in a product with batch no. IB20056, however, Cipla recalled all products from other batches that were manufactured using the same lot of valves as the defected batch.
The company said that there is a probability that the device defect may fail to deliver the recommended dose to treat respiratory symptoms such as wheezing cough, shortness of breath, and bronchospasms, which in turn could prove life-threatening. A release noted that there were no adverse events reported for albuterol sulfate inhalation aerosol related to this recall.
As per the release, Cipla sent the recall notice to their nationwide distributors informing that arrangements for return and replacement of all recalled products were in progress. In the meanwhile, anyone in possession of the recalled products was asked to immediately stop usage.