FDA MedWatch - Nitroglycerin Lingual Spray by Padagis:

U.S. Food and Drug Administration sent this bulletin at 12/28/2021 07:04 AM EST

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Nitroglycerin Lingual Spray by Padagis: Recall - Due to a Possible Defective Delivery System

AUDIENCE: Patient, Health Professional, Pharmacy, Cardiology

ISSUE: Padagis is recalling lots of Nitroglycerin Lingual Spray due to a complaint received that a unit may not dispense. There is a remote risk that the product may not properly dispense medication to patients in the event of a malfunction of their dispensing unit. This recall applies only to the 12 g spray bottle and not the 4.9 g spray bottle of this medication.

Risk Statement: If the product does not deliver the appropriate amount of nitroglycerin, the patient will likely continue to experience chest pain. The label advises that if relief is not obtained after 3 doses over 15 minutes the patient should promptly seek medical attention.

To date, Padagis has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of chest pain due to coronary artery disease in adult patients.

RECOMMENDATIONS:

All customers, healthcare providers, and consumers are instructed to examine their inventory for Nitroglycerin Lingual Spray, 12 g immediately and to quarantine, discontinue the distribution and use of, and return as directed all recalled lots of the product.
All customers who have distributed this product to consumers have been requested to identify their customers and notify them immediately of this product recall. Healthcare providers, distributors, and retailers that have product which is being recalled should stop distribution.
Patients who have this product should contact their healthcare provider for an alternate replacement before returning the recalled product.
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product or any medical concerns.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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