D-0228-2018 Class II Terminated

Recalled by Unichem Pharmaceuticals Usa Inc — Hasbrouck Heights, NJ

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