Source – Cipla
On July 10 2023, Cipla, a pharmaceutical company that recently received a 23-page Form 483 filing from the FDA, is exacerbating the shortage of albuterol by recalling six batches of the asthma medication in the United States.
According to a filing with the Bombay Stock Exchange, Cipla stated that the voluntary recall of albuterol sulfate inhalation aerosol is due to a container defect. The company specifically mentioned a market complaint regarding leakage in one inhaler.
Upon discovering the leak in the inhaler valve, Cipla decided to remove all lots of the drug that utilized the same batch of valves from store shelves in the US This action was taken as a precautionary measure, according to the company.
The affected lots were manufactured in November 2021 and are set to expire this November.
In its filing, Cipla emphasized that it adheres to strict quality processes for identifying defects and safety concerns. The company has committees composed of subject-matter experts, quality management personnel, and medical safety experts who regularly investigate and assess these issues.
Cipla’s facility in Pithampur, India, recently received a highly critical Form 483 from the FDA. During an inspection in February, the FDA discovered over 3,000 complaints filed against the company between 2020 and 2022, with more than 90% of them mentioning product performance problems. The FDA claimed that Cipla did not take appropriate action in response to the complaints, failing to evaluate or mitigate them.
Furthermore, the FDA noted that the Pithampur facility experienced eight power failures since January 2021, and Cipla did not investigate how these outages might have affected product quality.
This is not the first time the FDA has raised concerns about a Cipla plant. In a 2020 inspection of a sterile products plant in Goa, India, the FDA found product residue on equipment and around air filters, as well as a failure to conduct a comprehensive review of batch discrepancies. The company was also criticized for issues related to cross-contamination and quality assurance discrepancies.
The supply of albuterol inhalers in the US has been limited since Akorn Pharmaceuticals, the sole manufacturer of a particular dose of liquid albuterol, declared bankruptcy and ceased operations in February. The FDA mentioned in a tweet that this dose is commonly used in hospitals. Other drugmakers, such as Sun Pharma and Ritedose, have also encountered supply disruptions with albuterol, as reported by the American Society of Health-System Pharmacists.
