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Recall Observatory FDA recall evidence

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

D-0372-2022

December 27, 2021

Class II

Product summary

Firm
Padagis US LLC
Event
Event 89310
Status
Terminated
Classification
Class II
Quantity
11,868 bottles
Official record key
drug-enforcement:D-0372-2022

Official wording

Reason: Defective Delivery System

Code information: Lot, expiry: Lot 150892, exp Oct 2022; Lot 153199, exp Feb 2023; Lot 156041, exp Apr 2023

Distribution pattern: Nationwide USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Delivery System