Drug product
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01
D-0507-2019
Product summary
- Event
- Event 82085
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,656 bottles
- Official record key
drug-enforcement:D-0507-2019
Official wording
Reason: Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Code information: Lot #: C802676, Exp 03/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification