D-0228-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 24, 2018
- Initiation Date
- December 19, 2017
- Termination Date
- September 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96,876 Bottles of 30s
Product Description
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
Reason for Recall
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Distribution Pattern
Product was distributed nationwide in the USA.
Code Information
Lot: ZDPH17040