Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets ...
FDA Recall #D-127-2013 — Class III — December 10, 2012
Product Description
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.
Reason for Recall
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Recalling Firm
Upsher Smith Laboratories, Inc. — Maple Grove, MN
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
11,316 bottles
Distribution
Nationwide and Puerto Rico
Code Information
Lot #: 310162, Exp 09/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated