Drug product
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
D-1583-2019
Product summary
- Event
- Event 83460
- Status
- Terminated
- Classification
- Class II
- Quantity
- 828 100-count unit dose cartons
- Official record key
drug-enforcement:D-1583-2019
Official wording
Reason: cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Code information: Lot# M02250 EXP 10/2020.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
cGMP deviations