Amneal Pharmaceuticals of New York, LLC: Drug Recall

Recall #D-0477-2024 · 03/25/2024

Class II: Risk

Recall Details

Recall Number: D-0477-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Amneal Pharmaceuticals of New York, LLC
Status: Completed
Date Initiated: 03/25/2024
Location: Brookhaven, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2784 bottles

Reason for Recall

Failed Dissolution Specifications

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.

Distribution Pattern

US Nationwide.

Other Recalls by Amneal Pharmaceuticals of New York, LLC

Class I: Dangerous 03/21/2024

Superpotent Drug: Due to overfilling of drug powder
Class II: Risk 02/13/2024

Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class II: Risk 01/15/2024

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class II: Risk 12/26/2023

Failed dissolution specifications
Class II: Risk 10/27/2023

Failed Dissolution Specifications

View all recalls by Amneal Pharmaceuticals of New York, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.