Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, M...
FDA Recall #D-1362-2022 — Class II — July 27, 2022
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.
Recalling Firm
Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4,309 bottles
Distribution
USA nationwide
Code Information
Lot #: AR210705, Exp 04/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated