Unichem Pharmaceuticals Usa Inc recalls Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories…

Recall date

December 19, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0228-2018

FDA classification

Class II

Brand / firm

Unichem Pharmaceuticals Usa Inc

Sold / distributed

Product was distributed nationwide in the USA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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