Padagis Issues Voluntary Nationwide Recall for Nitroglycerin Lingual Spray Due to a Possible Defective Delivery System

If your email program has trouble displaying this email, view as a webpage. Padagis Issues Voluntary Nationwide Recall for Nitroglycerin Lingual Spray Due to a Possible Defective Delivery System FOR IMMEDIATE RELEASE - Allegan, Michigan – December 27, 2021 – Padagis US LLC announced today it has issued a voluntary nationwide recall to the consumer/user level of the lots of Nitroglycerin Lingual Spray listed in the table below. Out of an abundance of caution, this product is being recalled from the market 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 12g spray bottle and not the 4.9g spray bottle of this medication. Drug NDC Strength Net Contents Lot # Expiration Nitroglycerin Lingual Spray 45802-210-02 400 mcg per spray 12 g 150892 Oct 2022 153199 Feb 2023 156041 Apr 2023   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.

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