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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

The Harvard Drug Group: Memantine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failure

Agency Publication Date: May 13, 2020
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Summary

The Harvard Drug Group is recalling 678 cartons of Memantine Hydrochloride Extended-Release Capsules (28 mg), a medication used to treat symptoms of Alzheimer's disease. The recall was initiated because routine stability testing showed the drug failed to dissolve properly (low stage 3 dissolution results). This failure means the medication may not release into the body as intended, potentially reducing its effectiveness for patients. These prescription capsules were distributed in Alabama, Florida, Iowa, New York, Ohio, and Texas.

Risk

If the medication fails to dissolve according to specifications, the patient may not receive the full intended dose of the drug, which can lead to poorly controlled symptoms of the condition being treated. No specific injuries or adverse events have been reported to date.

What You Should Do

  1. Check your medication packaging for Memantine Hydrochloride Extended-Release Capsules, 28 mg (100 capsules per unit dose carton) with NDC number 0904-6735-61.
  2. Verify if your product belongs to the affected lots: M02199D or M02246D, both with an expiration date of 5/2020.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if your medication is part of this recall.
  4. Return any unused capsules from the affected lots to your pharmacy to receive a refund and ensure the product is properly disposed of.
  5. Contact the manufacturer, The Harvard Drug Group, or the distributor, Major Pharmaceuticals, at 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 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 your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Patients should contact their medical professional or pharmacy to return the affected lots and secure a refund or replacement medication.

Affected Products

Product: Memantine Hydrochloride Extended-Release Capsules, 28 mg (100 capsules per unit dose cartons)
Model:
NDC: 0904-6735-61
Recall #: D-1262-2020
Lot Numbers:
M02199D (Exp 5/2020)
M02246D (Exp 5/2020)
Date Ranges: Expiration 5/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85566
Status: Resolved
Manufacturer: The Harvard Drug Group
Sold By: Major Pharmaceuticals
Manufactured In: India, United States
Units Affected: 678 cartons
Distributed To: Alabama, Florida, Iowa, New York, Ohio, Texas

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.