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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

Amneal Pharmaceuticals, Inc.: Methylergonovine Maleate Tablets Recalled for Presence of Foreign Medication

Agency Publication Date: August 2, 2019
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Summary

Amneal Pharmaceuticals is recalling approximately 2,496 bottles of Methylergonovine Maleate (0.2 mg tablets), a medication used to prevent or treat bleeding after childbirth. The recall was initiated after a bottle was found to contain one tablet of Promethazine, a different medication used for allergies or nausea. Taking the wrong medication can lead to unexpected side effects or a lack of the intended treatment for postpartum bleeding.

Risk

The presence of a foreign tablet (Promethazine) in a bottle of Methylergonovine Maleate poses a risk that a patient may accidentally ingest the wrong medication, potentially resulting in adverse drug reactions or failure to receive the prescribed treatment for bleeding after childbirth.

What You Should Do

  1. Check your prescription bottle to see if it is Methylergonovine Maleate USP 0.2 mg Tablets in either 12-count bottles (NDC 69238-1605-02) or 28-count bottles (NDC 69238-1605-08).
  2. Verify the lot number and expiration date on the label: check for Lot # BA10619A or Lot # BA10619B with an expiration date of 07/2020.
  3. If you have an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on obtaining a safe replacement.
  4. Return any unused product from the affected lots to your pharmacy for a refund.
  5. Contact Amneal Pharmaceuticals, Inc. at their Brookhaven, New York location if you have questions regarding this recall.
  6. For additional information 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: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Methylergonovine Maleate USP 0.2 mg Tablets (12 count)
Model:
NDC 69238-1605-02
Recall #: D-1516-2019
Lot Numbers:
BA10619A (Exp 07/2020)
Date Ranges: Expiration date 07/2020
Product: Methylergonovine Maleate USP 0.2 mg Tablets (28 count)
Model:
NDC 69238-1605-08
Recall #: D-1516-2019
Lot Numbers:
BA10619B (Exp 07/2020)
Date Ranges: Expiration date 07/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83206
Status: Resolved
Manufacturer: Amneal Pharmaceuticals, Inc.
Sold By: Three major distributors
Manufactured In: United States
Units Affected: a) 2,256 bottles; b) 240 bottles
Distributed To: Nationwide

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.