Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by...
FDA Recall #D-0228-2018 — Class II — December 19, 2017
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.
Recalling Firm
Unichem Pharmaceuticals Usa Inc — Hasbrouck Heights, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
96,876 Bottles of 30s
Distribution
Product was distributed nationwide in the USA.
Code Information
Lot: ZDPH17040
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated