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COVID-19

Nitroglycerin Lingual Spray Recalled Due to a Possible Defective Delivery System

On December 27, 2021, Padagis US LLC announced its voluntary nationwide recall of Nitroglycerin Lingual Spray due to a remote risk that the dispensing unit may malfunction and not properly dispense medication. Nitroglycerin Lingual Spray is used for acute relief of an attack or prophylaxis of chest pain due to Coronary Artery Disease in adult patients. If the product does not deliver the appropriate amount of nitroglycerin, the patient will likely continue to experience chest pain.

This recall applies only to the 12g spray bottle and not the 4.9g spray bottle. All health care providers, distributers and retailers are instructed to examine their inventory for Nitroglycerin Lingual Spray, 12g immediately and to quarantine, discontinue the distribution and use of, and return as directed all recalled lots of the product.

Patients who have this product should contact their health care provider for an alternate replacement before returning the recalled product. Patients should also contact their physician or health care provider if they have experienced any problems that may be related to using this product or any medical concerns.

References:

  1. Center for Drug Evaluation and Research. (2021, December 27). Padagis Issues Voluntary Nationwide Recall for Nitroglycerin Lingual Spray Due to a Possible Defective Delivery System. U.S. Food and Drug Administration. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/padagis-issues-voluntary-nationwide-recall-nitroglycerin-lingual-spray-due-possible-defective?utm_medium=email&utm_source=govdelivery
  2. Nitroglycerin prescribing information. Revised 1/2015.
Published on: January 17, 2022, 15:25 p.m. ET
Last updated on: January 14, 2022, 15:30 p.m. ET