[9/21/2020] The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Company in Minneapolis, due to possible clogging of the inhaler resulting in patients not receiving enough or any medicine. This recall is to the retail level. FDA urges patients to continue using the inhaler they have on hand.

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 (COPD). Patients could face Health risks if their rescue albuterol inhaler malfunctions and does not relieve symptoms in an emergency situation. 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 doctor;
• have extra inhalers or an alternative treatment available in case of malfunction, as some of these recalled inhalers stop working after several uses; and
• contact their health care professional or pharmacist with questions.

FDA reminds Health care professionals and patients that albuterol inhalers are available through additional manufacturers.

Perrigo informed FDA it has received several thousand complaints about its product. Most of the complaints were for clogging and failure to dispense enough medicine. The manufacturer of Perrigo’s albuterol inhaler, Catalent, stopped producing and distributing the albuterol inhaler products on August 21, 2020, and is currently investigating the malfunction.

The agency asks health care professionals and patients to report unexpected side effects or quality problems associated with albuterol inhalers to FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.