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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Event Detail

Event ID 64085
Product Type Drugs
Status Ongoing
Recalling Firm Upsher Smith Laboratories, Inc.
City Maple Grove
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-10
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot #: 310162, Exp 09/14 Class III Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label. 11,316 bottles D-127-2013