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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

Torrent Pharma Inc.: Carbamazepine Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: May 29, 2020
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Summary

Torrent Pharma Inc. is recalling 6,228 bottles of Carbamazepine (Tegretol), a prescription medication used to treat seizures and nerve pain. The recall was initiated because the tablets failed dissolution specifications, meaning they may not dissolve properly in the body. If the drug does not dissolve correctly, it may not be absorbed into the bloodstream at the intended rate, potentially leading to lower-than-expected levels of medication in the system. Consumers should consult their healthcare provider or pharmacist regarding their medication.

Risk

The failure to meet dissolution specifications can result in the medication not working as intended. For patients relying on Carbamazepine to prevent seizures or manage chronic pain, inconsistent absorption could lead to a loss of symptom control or an unexpected return of seizure activity.

What You Should Do

  1. Check your prescription bottle to see if it is Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle with NDC 13668-268-05.
  2. Verify if your medication belongs to Lot # 4FF4F001 with an expiration date of 1/2023.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement or alternative prescription before you stop taking the medication.
  4. Return any unused product from the affected lot to your pharmacy for a refund.
  5. Contact Torrent Pharma Inc. at 1-800-912-9561 for further instructions regarding this recall.
  6. For additional questions or to report side effects, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and pharmacy refund

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

Affected Products

Product: Carbamazepine Tablets, USP 200 mg (500-count bottle)
Model:
NDC 13668-268-05
Recall #: D-1317-2020
Lot Numbers:
4FF4F001 (Exp 1/2023)
Date Ranges: Expiration 1/2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85644
Status: Resolved
Manufacturer: Torrent Pharma Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 6228 Bottles
Distributed To: Nationwide
Agency Last Updated: June 18, 2020

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.