Drug product
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
D-1133-2019
Product summary
- Event
- Event 82617
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33,958 bottles
- Official record key
drug-enforcement:D-1133-2019
Official wording
Reason: cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Code information: Lot #: a) C802629, Exp. 03/2020; C805680, Exp. 07/2020, C808821,Exp. 10/2020; b) C806561, Exp. 10/2020
Distribution pattern: Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
Derived failure modes
-
Manufacturing or process control
cGMP deviations