Home / Recalls / Amneal Pharmaceuticals of New York, LLC / D-1362-2022

D-1362-2022 Class II Terminated

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

Recall Details

Product Type: Drugs
Report Date: August 31, 2022
Initiation Date: July 27, 2022
Termination Date: August 17, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,309 bottles

Product Description

Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10

Reason for Recall

Failed dissolution specifications.

Distribution Pattern

USA nationwide

Code Information

Lot #: AR210705, Exp 04/2024

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