Drug product
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
D-0617-2017
Product summary
- Event
- Event 76737
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32628 bottles
- Official record key
drug-enforcement:D-0617-2017
Official wording
Reason: Failed Dissolution Specifications; 9 month long term stability
Code information: a) MR8221, MR8222 exp 7/31/2017; MR10260, exp 9/30/2017; MR10926, exp 10/31/2017; b) MR6187, exp 5/31/2017; MR7302, exp 6/30/2017; MR7768, MR7769, exp 7/31/2017; MR8247, exp 7/31/2017; MR8887, MR8892, MR8893 exp 8/31/2017; MR9014, MR10414 exp 9/30/2017; MR10928, exp 10/31/2017; MR11183, MR11185, MR11186, exp 11/30/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications