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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

Glenmark Rizatriptan Benzoate Tablets Recalled for Impurity Levels

Agency Publication Date: June 4, 2024
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Summary

Glenmark Pharmaceuticals Inc., USA is recalling 15,696 cartons of Rizatriptan Benzoate Orally Disintegrating Tablets (5mg and 10mg strengths). These medications, which are used to treat migraine headaches, are being recalled because they contain an impurity called N-Nitroso Desmethyl Rizatriptan at levels exceeding the FDA's acceptable limit. The recall includes specific lots of 18-count unit-dose cartons with expiration dates ranging from July 2024 to June 2025.

Risk

The impurity N-Nitroso Desmethyl Rizatriptan is a type of nitrosamine, which is classified as a potential carcinogen. Long-term exposure to these impurities above acceptable levels may increase the risk of developing cancer.

What You Should Do

  1. This recall affects Glenmark Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg and 10mg, sold in 18 (3 x 6) unit-dose tablet cartons distributed nationwide across the United States.
  2. Identify the 5mg tablets by NDC code 68462-467-06 and lot numbers 19224857 (Exp. 11/2024) or 19232493 (Exp. 6/2025).
  3. Identify the 10mg tablets by NDC code 68462-468-06 and lot numbers 19223402 (Exp. 7/2024), 19224858 (Exp. 11/2024), or 19232492 (Exp. 6/2025).
  4. 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 Glenmark Pharmaceuticals Inc., USA for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

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: Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg (18 Unit-Dose Tablets)
Variants: 5mg, Orally Disintegrating Tablets
Lot Numbers:
19224857 (Exp. 11/2024)
19232493 (Exp. 6/2025)
NDC:
68462-467-06

Recall #: D-0534-2024; Product of India; 2400 cartons affected.

Product: Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg (18 Unit-Dose Tablets)
Variants: 10mg, Orally Disintegrating Tablets
Lot Numbers:
19223402 (Exp. 7/2024)
19224858 (Exp. 11/2024)
19232492 (Exp. 6/2025)
NDC:
68462-468-06

Recall #: D-0535-2024; Product of India; 13296 cartons affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94608
Status: Active
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Wholesalers; Retail Pharmacies
Manufactured In: India
Units Affected: 2 products (2400 cartons; 13296 cartons)
Distributed To: Nationwide
Agency Last Updated: June 13, 2024

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.

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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.