Drug product

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

D-1041-2017

May 10, 2017

Class II

Product summary

Firm: Zydus Pharmaceuticals USA Inc
Event: Event 77674
Status: Terminated
Classification: Class II
Quantity: 108,096 HDPE bottles
Official record key: drug-enforcement:D-1041-2017

Official wording

Reason: Failed Dissolution Specifications

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

Distribution pattern: Nationwide

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Dissolution Specifications