Drug product
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
D-1291-2022
Product summary
- Event
- Event 90495
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9552 bottles
- Official record key
drug-enforcement:D-1291-2022
Official wording
Reason: Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Code information: Lot: HAC1312A, EXP. 05/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications