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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
Telephone
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
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