Possible Defective Delivery System Prompts Recall of Nitroglycerin Lingual Spray

Padagis US is voluntarily recalling 3 lots of Nitroglycerin Lingual Spray to the user level due to a complaint received that a unit may not properly dispense medication.

Nitroglycerin Lingual Spray is indicated for the acute relief of an attack or prophylaxis of chest pain due to coronary artery disease in adult patients. The recalled lots of Nitroglycerin Lingual Spray, 400mcg per spray; NDC Number 45802-210-02; 12g spray bottle, were distributed nationwide and include the following:

• Lot Number 150892; Expiration Date Oct 2022;
• Lot Number 153199; Expiration Date Feb 2023;
• Lot Number 156041; Expiration Date Apr 2023.

According to the Company, the product is being recalled out of an abundance of caution that the product may not properly dispense medication. To date, the Company has not received any reports of adverse events related to this recall.

Consumers or health care workers with any questions regarding this recall should contact Sedgwick at [email protected] or (888) 266-7912.

Adverse events or quality concerns should be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting program. 

Reference

Padagis issues voluntary nationwide recall for Nitroglycerin Lingual Spray due to a possible defective delivery system. News release. Padagis US LLC. December 27, 2021. Accessed December 28, 2021. https://prnmedia.prnewswire.com/news-releases/padagis-issues-voluntary-nationwide-recall-for-nitroglycerin-lingual-spray-due-to-a-possible-defective-delivery-system-301450890.html