Indian pharmaceutical company Cipla has announced that its US unit is recalling six batches of albuterol sulfate inhalation aerosol due to a container defect, Reuters reported. The recall was initiated following a market complaint about a single inhaler where leakage was observed through the inhaler valve.

Details of the Recall

The six batches, manufactured in November 2021 using the same lot of valves, are being recalled. Cipla’s “Albuterol Sulfate HFA Inhalation Aerosol” is a generic therapeutic equivalent version of an inhaler from Merck & Co.

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No Adverse Events Reported

Despite the recall, Cipla stated that there have been no adverse events reported in relation to the inhaler. However, the company warned that a failure to deliver the recommended dose to treat the respiratory symptoms of acute asthma exacerbations, including wheezing and bronchospasms, due to a device defect, could be “life-threatening”.

Instructions for Consumers

Cipla has advised consumers to stop using, return to the place of purchase, or discard the inhalers. The company also added that adverse reactions to the use of the product could be reported to the U.S. health agency.

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