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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

Amneal Methylergonovine Maleate Tablets Recalled for Dissolution Failure

Agency Publication Date: April 30, 2024
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Summary

Amneal Pharmaceuticals of New York, LLC is recalling 2,784 bottles of Methylergonovine Maleate Tablets, USP (0.2mg) because the drug failed dissolution testing. This means the tablets may not dissolve at the required rate in the body, which could potentially reduce the effectiveness of the medication. The recall affects 12-count prescription bottles used primarily to help control bleeding after childbirth.

Risk

If the medication fails to dissolve properly, it may not be absorbed into the bloodstream at the correct dosage, which could lead to a loss of efficacy in managing postpartum bleeding. No specific injuries or incidents have been reported to date regarding this issue.

What You Should Do

  1. This recall affects 12-count bottles of Methylergonovine Maleate Tablets, USP (0.2mg) distributed by Amneal Pharmaceuticals with NDC # 69238-1605-2 and lot number BJ01922A (expiration date 03/2024).
  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 the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional assistance.

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: Methylergonovine Maleate Tablets, USP (0.2mg)
Variants: 12-count bottle, 0.2mg, Rx Only
Lot Numbers:
BJ01922A (Exp 03/2024)
NDC:
69238-1605-2

Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807; Product ID 206839.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94286
Status: Resolved
Manufacturer: Amneal Pharmaceuticals of New York, LLC
Manufactured In: United States
Units Affected: 2784 bottles
Distributed To: Nationwide
Agency Last Updated: May 8, 2024

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.