Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufa...
FDA Recall #D-0372-2022 — Class II — December 27, 2021
Product Description
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
Recalling Firm
Padagis US LLC — Minneapolis, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
11,868 bottles
Distribution
Nationwide USA
Code Information
Lot, expiry: Lot 150892, exp Oct 2022; Lot 153199, exp Feb 2023; Lot 156041, exp Apr 2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated