PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 24, 2018 Initiated: December 19, 2017 #D-0228-2018

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.

Details

Units Affected
96,876 Bottles of 30s
Distribution
Product was distributed nationwide in the USA.
Location
Hasbrouck Heights, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Unichem Pharmaceuticals Usa Inc. Units affected: 96,876 Bottles of 30s.
Why was this product recalled?
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 24, 2018. Severity: Moderate. Recall number: D-0228-2018.