Drug Safety Alerts

Nitroglycerin Lingual Spray, 400mcg/Spray 12g Bottle Consumer-Level Recall

12/27/2021

On December 27, 2021, Padagis issued a consumer-level recall of certain lots of Nitroglycerin Lingual Spray, 400mcg/Spray 12g Bottle NDC # 45802-0210-02 distributed by Perrigo. This recall was issued due to possible failure of the product to properly dispense medication. There is the potential for some units to contain a disassembled pump, affecting the ability to dispense medication. There is a remote probability that medically reversible, transient and/or serious adverse health consequences could occur in patients experiencing angina pectoris who are unable to use their device.

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

This recall affects lot numbers 150892 exp.10/22, 153199 exp. 02/23 and 156041 exp. 04/23.

Perrigo recommends that consumers who have affected product obtain replacement before returning the recalled product.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies. CVS Specialty indicated they were not affected by this recall.

For more information about this recall, please call the Padagis Call Center at 1-800-719-9260. 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 https://www.fda.gov.