Drug Enforcement D-0477-2024

Failed Dissolution Specifications

Status

Completed

Classification

Class II

Report Date

May 8, 2024

Termination Date

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Product Information

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.
Product quantity
2784 bottles
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
US Nationwide.

Location & Firm

Recalling firm
Amneal Pharmaceuticals of New York, LLC
Address
50 Horseblock Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0477-2024
Event ID
94286
Recall initiation date
March 25, 2024
Center classification date
April 29, 2024
Code info
Lot #: BJ01922A, exp. date 03/2024
More code info
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