Amneal Pharmaceuticals of New York, LLC: Drug Recall

Recall #D-1362-2022 · 07/27/2022

Class II: Risk

Recall Details

Recall Number
D-1362-2022
Classification
Class II
Product Type
Drug
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Status
Terminated
Date Initiated
07/27/2022
Location
Brookhaven, NY, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,309 bottles

Reason for Recall

Failed dissolution specifications.

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

Distribution Pattern

USA nationwide

Other Recalls by Amneal Pharmaceuticals of New York, LLC

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.