Safety Report: Perrigo Nitroglycerin Lingual Spray - recalled due to improper dispense medication, USA

United States

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 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: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 150892
- Expiration: Oct 2022

- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 153199
- Expiration: Feb 2023

- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 156041
- Expiration: Apr 2023

Company name: Padagis
Brand name: Perrigo
Product recalled: Nitroglycerin Lingual Spray
Reason of the recall: Unit may not properly dispense medication.
FDA Recall date: December 27, 2021

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.

Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of chest pain due to coronary artery disease in adult patients. All packaging and branding on affected units is that of Perrigo Company PLC. The product is packaged in a 12 g bottle contained within a carton. The medication was distributed Nationwide in the USA to wholesalers and retailers.

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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/padagis-issues-voluntary-nationwide-recall-nitroglycerin-lingual-spray-due-possible-defective

Source: FDA