PlainRecalls
FDA Drug Moderate Class II Completed

Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.

Reported: May 8, 2024 Initiated: March 25, 2024 #D-0477-2024

Product Description

Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.

Reason for Recall

Failed Dissolution Specifications

Details

Units Affected
2784 bottles
Distribution
US Nationwide.
Location
Brookhaven, NY

Frequently Asked Questions

What product was recalled?
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.. Recalled by Amneal Pharmaceuticals of New York, LLC. Units affected: 2784 bottles.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on May 8, 2024. Severity: Moderate. Recall number: D-0477-2024.