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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

Lupin Penicillamine Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: December 13, 2023
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Summary

Lupin Pharmaceuticals Inc. is recalling one lot of Penicillamine Tablets USP (250 mg), a prescription medication used to treat conditions such as Wilson's disease and rheumatoid arthritis. The recall was issued because the tablets failed dissolution testing, meaning they may not dissolve at the correct rate to be effectively absorbed by the body. This specific recall involves 100-count bottles of the medication distributed to three wholesale or distributor accounts.

Risk

If the medication fails to dissolve properly, the patient may not receive the intended therapeutic dose, which could lead to reduced effectiveness in treating their underlying medical condition. No injuries or adverse events have been reported in connection with this specific defect.

What You Should Do

  1. This recall affects Penicillamine Tablets USP 250 mg, sold in 100-count bottles under NDC 70748-153-01, specifically Lot # M200498 with an expiration date of June 2024.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Penicillamine Tablets USP 250 mg (100-count bottle)
Variants: 250 mg, Tablet
Lot Numbers:
M200498 (Exp. June 2024)
NDC:
70748-153-01

Manufactured by Lupin Limited, Nagpur-441 108, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93482
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: wholesalers; distributors
Manufactured In: United States, India
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.