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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

RemedyRepack Inc.: Carbamazepine 200 mg Tablets Recalled for Failed Dissolution Specification

Agency Publication Date: July 14, 2020
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Summary

RemedyRepack Inc. has recalled Carbamazepine 200 mg tablets, a prescription medication used to treat seizures and nerve pain, because the tablets did not dissolve properly during routine quality testing. Approximately 498 tablets are affected by this recall. When a drug fails dissolution testing, it means the medication may not be absorbed correctly by the body, which could prevent the patient from receiving the necessary dose.

Risk

The drug failed to meet 'out-of-specification' dissolution results, meaning the tablets do not break down at the required rate. This could lead to lower-than-intended levels of the medication in a patient's bloodstream, potentially failing to control seizures or manage pain effectively.

What You Should Do

  1. Check your medication packaging for Carbamazepine 200 mg Tablets in 100-unit dose boxes with the following identifiers: Box NDC 70518-2489-00 or Unit Dose NDC 70518-2489-01.
  2. Verify if your medication belongs to Lot number B0796217-020920 with an Expiration Date of 02/28/2021.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you are taking this specific lot of medication. Do not stop taking your medication without consulting a professional, as suddenly stopping an anti-seizure drug can cause health complications.
  4. Return any unused tablets from the affected lot to your pharmacy for a refund.
  5. Contact RemedyRepack Inc. directly at their facility in Indiana, Pennsylvania, for further instructions regarding this recall.
  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
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Carbamazepine 200 mg Tablets (100-unit dose tablets per box)
Model:
NDC 70518-2489-00 (box)
NDC 70518-2489-01 (unit dose)
Lot Numbers:
B0796217-020920 (Exp. 02/28/2021)
Date Ranges: 02/28/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86006
Status: Resolved
Manufacturer: RemedyRepack Inc.
Sold By: pharmacies; healthcare providers
Manufactured In: United States
Units Affected: 498 tablets
Distributed To: Minnesota

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.