Cipla recalls six batches of albuterol inhalers for container defect

Key takeaways:

• Cipla voluntarily recalled six batches of albuterol sulfate inhalation aerosol 90 mcg after a leak was identified.
• The manufacturer recommends to stop using products affected by the recall.

Six batches of albuterol sulfate inhalation aerosol 90 mcg (200 metered inhalation) were voluntarily recalled by the manufacturer due to container defects that may prevent them from releasing the proper dose.

The product is used to prevent exercise-induced bronchospasm and to treat and prevent bronchospasm with reversible obstructive airway disease.

According to a statement released by the manufacturer, Cipla, and distributed by the FDA, the recall was made in the United States “out of an abundance of caution” following a market complaint that one inhaler leaked through the inhaler valve.

The release states that “there is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of acute asthma exacerbations such as wheezing, coughing, shortness of breath and bronchospasms, due to device defect, may be life-threatening.”

The six batches included in the recall were manufactured with the same lot of inhaler valves as the one identified with a leak. They were manufactured in November 2021, and expire in November 2023.

No adverse events associated with this recall were reported at the time of its announcement.

In the release, Cipla stated that they will be notifying their customers and distributers via letter and will arrange for the return and replacement of products affected by the recall.

They also stated that those with recalled products should stop using them and discard them or return them to where they were purchased.