Home / Recalls / Zydus Pharmaceuticals USA Inc / D-1041-2017

D-1041-2017 Class II Terminated

Recalled by Zydus Pharmaceuticals USA Inc — Pennington, NJ

Recall Details

Product Type
Drugs
Report Date
August 9, 2017
Initiation Date
May 10, 2017
Termination Date
January 7, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
108,096 HDPE bottles

Product Description

Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Nationwide

Code Information

MR6317 Exp.05/17 MR6318 Exp. 05/17 MR6319 Exp. 05/17 MR5361 Exp. 06/17 MR9007 Exp. 08/17 MR10000 Exp. 08/17 MR10923 Exp. 10/17 MR10924 Exp. 10/17 MR10925 Exp. 10/17 MR11554 Exp. 11/17 MR11555 Exp. 11/17 MS1359 Exp. 12/17

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