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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

The Harvard Drug Group: Carbamazepine 200mg Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: September 17, 2021
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Summary

The Harvard Drug Group is recalling four cartons of Carbamazepine 200mg Tablets (generic Tegretol) due to a failure in dissolution specifications. This means the medication may not dissolve properly in the body, which can prevent the patient from receiving the intended dose of the medicine. These prescription tablets were manufactured by Torrent Pharmaceuticals and distributed in 100-count unit dose cartons. Consumers should contact their healthcare provider or pharmacist immediately to discuss alternative treatments and how to return the affected product.

Risk

If the tablets do not dissolve at the required rate, the medication may not be absorbed effectively, potentially leading to lower-than-expected blood levels of the drug. This could result in a loss of seizure control or a decrease in the effectiveness of the treatment for the underlying condition.

What You Should Do

  1. Check your medication packaging for Carbamazepine 200mg Tablets (USP) in 100-count unit dose cartons with NDC 0904-6172-61.
  2. Verify if your product matches lot number R01562 with an expiration date of 10/2022.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you find you have the affected medication.
  4. Do not stop taking your medication without consulting a healthcare professional, as sudden discontinuation of seizure medication can be dangerous.
  5. Return any unused portions of the affected lot to your pharmacy for a refund and contact The Harvard Drug Group for further instructions.
  6. For additional questions, 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

Healthcare consultation and product return

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

Affected Products

Product: Carbamazepine 200mg Tablets, USP (100 Count Unit Dose Cartons)
Model:
NDC 0904-6172-61
Recall #: D-0807-2021
Lot Numbers:
R01562 (Exp. 10/2022)
Date Ranges: 10/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88583
Status: Resolved
Manufacturer: The Harvard Drug Group
Sold By: MAJOR PHARMACEUTICALS
Manufactured In: India, United States
Units Affected: 4 Cartons of 100 count each
Distributed To: North Carolina

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.