Cipla US has announced a voluntary recall of 6 batches of albuterol MDIs after a report of valve leakage in a single inhaler manufactured in November 2021. The company said that no adverse events have been reported and that it is recalling all batches of the metered dose inhalers that used the same lot of valves out of “an abundance of precaution.”
The recalled batches of Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) are numbers IB20045, IB20055, IB20056, IB20057, IB20059, and IB20072, all manufactured in 2021 and all with an expiration date in November 2023. The inhaler with the reported leak came from batch number IB20056. Cipla says that the 6 batches were distributed to wholesalers and retailers across the US.
Cipla’s ANDA for its generic version of Proventil was approved by the FDA in April 2020.
Read the Cipla press release.
