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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Nitroglycerin Lingual Spray Recalled for Defective Delivery System

Agency Publication Date: January 13, 2022
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Summary

Padagis US LLC is recalling 11,868 bottles of Nitroglycerin Lingual Spray (400 mcg per spray) because of a defective delivery system that may prevent the medication from dispensing properly. This medication is used to treat sudden episodes of angina (chest pain), and failure to deliver the drug during an attack could be life-threatening. The recall includes 12 g bottles with 200 metered sprays distributed nationwide to pharmacies. No injuries or incidents have been reported to date.

Risk

A defective delivery system may cause the pump to fail or dispense an inaccurate dose. If a patient cannot receive their nitroglycerin during an acute chest pain episode, it can lead to serious cardiovascular complications or death.

What You Should Do

  1. The recalled product is Nitroglycerin Lingual Spray (400 mcg per spray, 200 metered sprays, 12 g bottles) with NDC 45802-210-02 and lot numbers 150892 (exp Oct 2022), 153199 (exp Feb 2023), and 156041 (exp Apr 2023).
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Nitroglycerin Lingual Spray (12 g bottles)
Variants: 400 mcg per spray, 200 metered sprays, Rx only
Lot Numbers:
150892 (exp Oct 2022)
153199 (exp Feb 2023)
156041 (exp Apr 2023)
NDC:
45802-210-02

Manufactured by Perrigo in Yeruham, Israel; Distributed by Perrigo in Allegan, MI.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89310
Status: Resolved
Manufacturer: Padagis US LLC
Sold By: pharmacies
Manufactured In: Israel, United States
Units Affected: 11,868 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.