Perrigo Recalls Albuterol Sulfate Inhalers Due to Possible Clogging

Perrigo has issued a voluntary recall of all unexpired albuterol sulfate inhalation aerosol to the retail level due to possible clogging of the inhaler, according to a recent FDA alert.¹

The FDA said that Perrigo has informed the agency that it received several thousand complaints about the product, with most of the complaints for clogging and failure to dispense enough medicine. The manufacturer of Perrigo’s inhaler, Catalent, stopped producing and distributing the products on August 21, 2020, and is currently investigating the malfunction. Albuterol inhalers are available through other manufacturers as well, according to the FDA.

The albuterol inhaler delivers medication into the body through the airway and lungs, where it opens the airways to treat asthma and other conditions, such as chronic obstructive pulmonary disease. According to the FDA, clogging of the inhaler can result in patients not receiving enough or any medicine. Patients could face health risks if their rescue albuterol inhaler malfunctions and does not relieve symptoms in an emergency situation.

The FDA advises patients to:

• Immediately seek emergency care if needed
• Use their Perrigo inhaler they have on hand, as needed and as directed by a provider
• Have extra inhalers or an alternative treatment available in case of malfunction, as some of these recalled inhalers stop working after several uses
• Contact their health care professional or pharmacist with questions

According to Perrigo, corrective action plans are underway, and a definitive timeline for product reintroduction has not been determined at this time.²

References

1. FDA Alerts of Perrigo’s voluntary albuterol inhaler recall. Drug Safety and Availability. FDA; September 21, 2020. Accessed September 22, 2020. https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-perrigos-voluntary-albuterol-inhaler-recall​
2. Perrigo Voluntarily Recalls Albuterol Sulfate Inhalation Aerosol; Reaffirms 2020 Guidance. Press release. Perrigo; September 17, 2020. Accessed September 22, 2020. https://www.prnewswire.com/news-releases/perrigo-voluntarily-recalls-albuterol-sulfate-inhalation-aerosol-reaffirms-2020-guidance-301133148.html​