FDA recall D-0372-2022

Padagis US LLC · Class II · drug

Product

Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02

Reason for recall

Defective Delivery System

Distribution

Nationwide USA

Key facts

Status: Terminated
Initiation date: 2021-12-27
Report date: 2022-01-19
Termination date: 2023-09-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0372-2022