Nitroglycerin Lingual Spray
FDA Recall NDC 45802-210
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nitroglycerin Lingual (NDC 45802-210). A significant event, classified as Class II, was initiated on Dec 27, 2021 by Padagis Israel Pharmaceuticals Ltd. The reported reason for this action was: "Defective Delivery System"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Delivery System
Dec 27, 2021
Jan 19, 2022
11,868 bottles
Recall Profile & Regulatory Data
Event ID
89310
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Padagis US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 28, 2023
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
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 150892, exp Oct 2022; Lot 153199, exp Feb 2023; Lot 156041, exp Apr 2023
Affected Packages Involved in this Recall
45802-210-01Product
45802-210-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
