Drug product
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01
D-0228-2018
Product summary
- Event
- Event 78786
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96,876 Bottles of 30s
- Official record key
drug-enforcement:D-0228-2018
Official wording
Reason: Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Code information: Lot: ZDPH17040
Distribution pattern: Product was distributed nationwide in the USA.
Derived failure modes
-
Unknown
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.