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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

Teva Pharmaceuticals USA: Mesalamine Delayed-Release Tablets Recalled for Failed Dissolution Testing

Agency Publication Date: March 2, 2020
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Summary

Teva Pharmaceuticals USA is recalling one lot of Mesalamine Delayed-Release Tablets (1.2 gram), a prescription medication used to treat certain bowel conditions. Approximately 3,695 bottles, each containing 120 tablets, are affected after stability testing showed the tablets did not dissolve properly. If the medication does not dissolve as intended, it may not be absorbed correctly by the body, potentially reducing the effectiveness of the treatment.

Risk

The tablets failed 'dissolution specifications,' meaning the medication may not release the active ingredient into the body at the correct rate or location in the digestive tract. This can lead to a lack of therapeutic effect, potentially causing a relapse or worsening of the patient's underlying inflammatory bowel symptoms.

What You Should Do

  1. Identify your medication by checking the bottle for Mesalamine Delayed-Release Tablets, USP, 1.2 gram in 120-count bottles with NDC 0591-2245-22.
  2. Check the side of the label for Lot #: 1342500A with an expiration date of 10/2020.
  3. If your medication matches this lot number and expiration date, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement.
  4. Do not stop taking your prescribed medication without first consulting a healthcare professional, as stopping treatment for inflammatory bowel conditions can lead to symptom flare-ups.
  5. Return any unused tablets from the affected lot to your pharmacy for a refund and contact Teva Pharmaceuticals for further instructions.
  6. For additional questions regarding this recall, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

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: Mesalamine Delayed-Release Tablets, USP, 1.2 gram (120-count bottle)
Model:
NDC 0591-2245-22
Recall #: D-0862-2020
Lot Numbers:
1342500A (Exp 10/2020)
Date Ranges: Expiration 10/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85017
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 3,695 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.