Drug recall D-0228-2018

Class II Terminated reported Jan 24, 2018

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

Reason for recall

Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.

Lots and codes

Lot: ZDPH17040

Recall details

Recalling firm
Unichem Pharmaceuticals Usa Inc, Hasbrouck Heights, NJ
Quantity
96,876 Bottles of 30s
Distribution
Product was distributed nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
December 19, 2017
Terminated
September 12, 2018

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