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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 Ranolazine Extended-Release Tablets Recalled for Dissolution Issues

Agency Publication Date: November 7, 2023
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Summary

Glenmark Pharmaceuticals Inc., USA has recalled 16,944 bottles of Ranolazine (ranolazine) Extended-Release Tablets 500mg, a medication used to treat chronic chest pain. The recall was initiated because the tablets failed dissolution specifications, meaning the drug may not dissolve at the required rate in the body. This recall affects 60-count bottles of the prescription medication distributed throughout the United States.

Risk

If the medication fails to dissolve as intended, the patient may receive too much or too little of the drug, which can lead to ineffective management of heart-related chest pain. No reports of injuries or adverse events were mentioned in the recall data.

What You Should Do

  1. The recalled medication is Glenmark Ranolazine Extended-Release Tablets 500mg (NDC 68462-319-60) in 60-count bottles, specifically lot 17230388 with an expiration date of 01/31/2025.
  2. If you have health concerns regarding your medication, contact your healthcare provider or pharmacist immediately.
  3. Return any unused product from the affected lot to the place of purchase for a refund, throw it away, or contact Glenmark Pharmaceuticals Inc., USA for further instructions.
  4. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

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: Ranolazine Extended-Release Tablets (500mg, 60-count bottle)
Variants: 500mg, Extended-Release, 60 Tablets per bottle
Lot Numbers:
17230388 (Exp. 01/31/2025)
NDC:
68462-319-60

Recall Number: D-0092-2024. Manufactured by Glenmark Pharmaceuticals Limited in India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93263
Status: Active
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Pharmacies; Healthcare Providers
Manufactured In: India
Units Affected: 16,944 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.