Drug Safety Alerts

Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL Consumer-Level Recall

4/25/2022

On April 25, 2022, Glenmark Pharmaceuticals Inc. issued a consumer-level recall of Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL manufactured by Glenmark Pharmaceutical Inc. This recall was issued due to lack of assurance of product sterility discovered after a review of the manufacturing facility's microbiology laboratory controls/processes and is being extended as a precaution to promote patient safety.

A complete list of affected products and lot numbers can be found here.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

Glenmark Pharmaceuticals Inc. has advised that consumers who are using recalled Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL to discontinue use and contact their physician or healthcare provider.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark® Mail Service Pharmacies.

For more information about the recall, please call Qualanex toll-free at 1-888-504-2012, 9:00 AM to 6:00 PM (EST). You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.