Nitroglycerin Lingual Spray Recall Issued Over Defective Delivery System

The recalled sprays are used to alleviate chest pain in patients with coronary artery disease.

Three lots of Perrigo nitroglycerin spray are being recalled due to a risk that they may not dispense the medication properly to users suffering chest pains.

The Perrigo Nitroglycerin Lingual Spray recall was announced by the FDA on December 27 after the manufacturer received complaints that the device may not dispense its medication properly. However, there have been no reports of injuries linked to the recalled nitroglycerin spray.

Nitroglycerin is often used by patients with coronary artery disease to provide acute and fast relief or prevention of chest pain, known as angina pectoris. It is also used to treat heart attacks, but in IV form.

Nitroglycerin lingual spray is applied under or onto the tongue via a pump sprayer. According to the recall notice, there is a small risk that the pump will malfunction and fail to dispense the medication properly.

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

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The recall affects Perrigo-brand Nitroglycerin Lingual Spray sold in 12g spray bottles, with an NDC number of 45802-210-02 sold in 400 mcg per spray strength. The recall includes lot number 150892 with an Oct 2022 expiration date; lot number 153199 with a Feb 2023 expiration date; and lot number 156041 with an Apr 2023 expiration date. The 4.9g spray bottles are not included in the recall.

The manufacturer is notifying all distributors and customers of the recall by express package delivery service and email and is arranging for the return of the recalled spray bottles. Padagis is asking all customers, healthcare providers and consumers to examine their inventory of Nitroglycerin Lingual Spray to see if the affected products are in their inventory,  and to immediately quarantine them, discontinue their distribution and return all recalled lots as directed.

Patients with the affected products are instructed to contact their healthcare provider for a replacement before returning the product.

Patients with questions about the recall can call 888-266-7912. Any adverse events should be reported to the FDA MedWatch Adverse Event Reporting program.


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