Class II
Drug Recall: 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, Bridgewate
Amneal Pharmaceuticals of New York, LLC · December 26, 2023
Reason for Recall
Failed dissolution specifications
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
Distribution
Product was distributed nationwide.
States Affected
NATIONWIDE
Quantity Affected
21,452/100 count bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0426-2024
Status: terminated
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