FDA Drug Class II — Moderate

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

Hazard

Failed Dissolution Specifications

Products

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,
Brand
Zydus Pharmaceuticals USA Inc
UPC
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

Units Affected

108,096 HDPE bottles