Recall: D-0228-2018

Class II - Potentially Harmful

Class IIClassification

2017-12-19Initiated

TerminatedStatus

Unichem Pharmaceuticals Usa InFirm

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

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

Distribution

Product was distributed nationwide in the USA.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.