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

Recall Number: D-1362-2022

Firm: Amneal Pharmaceuticals of New York, LLC

Classification: Class II

Status: Terminated

Report Date: 20220831

Initiation Date: 20220727

Termination Date: 20230817

Failed dissolution specifications.

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