Cipla, which was recently hit with a 23-page Form 483 filing from the FDA, is adding to the albuterol supply strain with a U.S. recall of six batches of the asthma med.The company's voluntary recall of albuterol sulfate inhalation aerosol is a result of a container defect, Cipla said in a filing with the Bombay Stock Exchange. Specifically, a market complaint flagged leakage in one inhaler, the company said.

The leak was spotted in the inhaler valve, leading Cipla to pull all of the lots of the drug that used that same batch of valves from U.S. shelves. The company made the move “out of an abundance of caution,” it noted in the release.

The lots were manufactured in November of 2021 and expire this November.

“Cipla maintains stringent quality processes to assess quality defects and safety issues,” the company said in the filing. “Cipla conducts regular investigation and assessment by committees consisting of subject-matter experts, quality management, medical safety experts.”

Cipla’s Pithampur, India, facility was recently the subject of a scathing Form 483 from the FDA. The FDA’s February inspection found more than 3,000 complaints filed against the company between 2020 and 2022, more than 90% of which mentioned product performance issues. Cipla didn’t take action regarding the complaints, according to the FDA, and failed to evaluate them or attempt to reduce the number of complaints.

Further, the facility suffered eight power failures since January 2021 and Cipla didn’t investigate how the outages might have affected quality, the agency noted.

The Form 483 wasn’t the first time the FDA found concerns at a Cipla plant. In a 2020 inspection of a Goa, India, sterile products plant, FDA inspectors found product residue on equipment and around air filters, plus a failure to conduct a complete review of batch discrepancies. The company was further slammed for issues relating to cross-contamination and quality assurance discrepancies. 

Meanwhile, the U.S. supply of albuterol inhalers has been tight since Akorn Pharmaceuticals, the only maker of a certain dose of liquid albuterol, filed for bankruptcy and shut down in February. The dose Akorn made is usually used in hospitals, the FDA noted in a tweet at the time. Other drugmakers experiencing supply hiccups of the drug include Sun Pharma and Ritedose, according to the American Society of Health-System Pharmacists.

Source: https://www.fiercepharma.com/manufacturing/cipla-pulls-six-batches-asthma-med-albuterol-after-leak-one-inhaler