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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.: Lamotrigine Extended-Release Tablets Recalled for Failed Dissolution Testing

Agency Publication Date: September 20, 2018
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Summary

Torrent Pharma Inc. has recalled 15,384 bottles of Lamotrigine Extended-Release Tablets (200 mg), a medication used to treat seizures and bipolar disorder. The recall was initiated because the tablets failed a dissolution test during stability testing, meaning they may not release the medication into the body at the correct rate. Consumers should contact their healthcare provider or pharmacist regarding this recall and to obtain a replacement prescription.

Risk

The tablets did not meet specifications for how the drug dissolves over a 5-hour period. If the medication dissolves too slowly or too quickly, it could lead to inconsistent blood levels of the drug, potentially reducing its effectiveness in controlling seizures or mood symptoms.

What You Should Do

  1. Check your prescription bottle for the product name 'Lamotrigine Extended-Release Tablets, USP, 200 mg' and NDC number 13668-342-30.
  2. Verify if your bottle is part of the affected lot: BFR5D002 with an expiration date of 11-2019.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and to obtain a replacement prescription; do not stop taking your medication without professional medical advice.
  4. Return any unused tablets from the affected lot to your pharmacy for a refund.
  5. Contact Torrent Pharma Inc. at their Basking Ridge, NJ office or through your distributor for further instructions regarding this recall.
  6. For additional questions or to report a problem, 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

Contact healthcare provider and return product for refund.

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

Affected Products

Product: Lamotrigine Extended-Release Tablets, USP, 200 mg (30 tablets per bottle)
Model:
NDC: 13668-342-30
Recall #: D-1204-2018
Lot Numbers:
BFR5D002 (Exp 11-2019)
Date Ranges: Expiration Date: 11-2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80985
Status: Resolved
Manufacturer: Torrent Pharma Inc.
Sold By: pharmacists; healthcare providers
Manufactured In: India
Units Affected: 15,384 30-count 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.