Home / Recalls / Amneal Pharmaceuticals of New York, LLC / D-0426-2024

D-0426-2024 Class II Terminated

Recalled by Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY

Recall Details

Product Type
Drugs
Report Date
April 3, 2024
Initiation Date
December 26, 2023
Termination Date
August 16, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21,452/100 count bottles

Product Description

Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10

Reason for Recall

Failed dissolution specifications

Distribution Pattern

Product was distributed nationwide.

Code Information

Lot # AR210704, exp. date 04/2024 AR210706, exp. date 04/2024 AR210707, exp. date 04/2024 AR210708, exp. date 04/2024 AR210709, exp. date 04/2024

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