Angina Spray Recalled Over Defective Delivery System

Padagis US LLC is voluntarily recalling 11,868 bottles of nitroglycerin lingual spray after receiving a report that the unit may not dispense correctly. The recall is included in the January 19, 2022, US Food and Drug Administration (FDA) Enforcement Report.

“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,” Padagis US stated in a December 27, 2021, company announcement. “This recall applies only to the 12 g spray bottle and not the 4.9 g spray bottle of this medication.”

Specifically, the recall affects nitroglycerin lingual spray, 400 mcg per spray, 200 metered sprays, 12 g bottles (NDC 45802-210-02), from lots 150892 (Exp. 10/22), 153199 (Exp. 2/23), and 156041 (Exp. 4/23). The product was manufactured by Perrigo, Yeruham, Israel, and distributed by Perrigo, Allegan, MI, throughout the United States. The packaging and branding on affected units are that of Perrigo Company PLC.

Padagis initiated the recall December 27, 2021. On January 13, 2022, the FDA designated the recall Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

“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,” the company advised.

Nitroglycerin lingual spray is a prescription medication indicated for acute relief of an attack or prophylaxis of chest pain due to coronary artery disease.