← FDA ENFORCEMENT
D-0477-2024Class II

Amneal Pharmaceuticals of New York, LLC

Recalling firm
Amneal Pharmaceuticals of New York, LLC
Product type
Drug
Status
Completed
Report date
2024-05-08
Distribution
US Nationwide.
Firm state
NY
Product quantity
2784 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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.

Code / lot info

Lot #: BJ01922A, exp. date 03/2024

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.