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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Mylan Pharmaceuticals Inc.: Nizatidine Capsules Recalled Due to Trace Impurity (NDMA) Detection

Agency Publication Date: January 20, 2020
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Summary

Mylan Pharmaceuticals Inc. has voluntarily recalled approximately 48,680 bottles of Nizatidine (150 mg and 300 mg) capsules, a prescription medication used to treat ulcers and GERD. Trace amounts of an impurity called N-nitrosodimethylamine (NDMA) were detected in the active pharmaceutical ingredient. These medications were distributed nationwide to wholesalers, retail pharmacies, and mail-order pharmacies between January 2020 and May 2021. Consumers should consult their healthcare provider for an alternative treatment and return the affected product to their pharmacy for a refund.

Risk

NDMA is classified as a probable human carcinogen. While trace amounts were detected, the impurity is a substance that could increase the risk of cancer over long-term exposure.

What You Should Do

  1. Check your prescription bottle for Nizatidine Capsules, USP 150 mg (NDC 0378-5150-91) with lot number 3086746 and expiration date May 2020.
  2. Check your prescription bottle for Nizatidine Capsules, USP 300 mg (NDC 0378-5300-93) with lot numbers 3082876 or 3082877, both with expiration dates of January 2020.
  3. Immediately contact your healthcare provider or pharmacist to discuss your treatment and obtain a replacement prescription before you stop taking the medication.
  4. Return any unused capsules from the affected lots to your pharmacy or the place of purchase for a refund.
  5. Contact Mylan Pharmaceuticals Inc. at 781 Chestnut Ridge Rd, Morgantown, West Virginia for further instructions regarding this recall.
  6. For additional questions or to report adverse effects, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and medical consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Nizatidine Capsules, USP 150 mg (60 capsules)
Model:
NDC 0378-5150-91
Recall #: D-0791-2020
Lot Numbers:
3086746 (Exp. May 2020)
Date Ranges: May 2020
Product: Nizatidine Capsules, USP 300 mg (30 capsules)
Model:
NDC 0378-5300-93
Recall #: D-0792-2020
Lot Numbers:
3082876 (Exp. January 2020)
3082877 (Exp. January 2020)
Date Ranges: January 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84607
Status: Resolved
Manufacturer: Mylan Pharmaceuticals Inc.
Sold By: wholesalers; distributors; retail pharmacies; charitable organizations; mail order pharmacies
Manufactured In: United States
Units Affected: 2 products (31,736 bottles of 60 capsules; 16,944 bottles of 30 capsules)
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.