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Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Ph...

FDA Recall #D-0477-2024 — Class II — March 25, 2024

Recall #D-0477-2024 Date: March 25, 2024 Classification: Class II Status: Completed

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

Recalling Firm

Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2784 bottles

Distribution

US Nationwide.

Code Information

Lot #: BJ01922A, exp. date 03/2024

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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