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Recall Observatory FDA recall evidence

Drug product

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.

D-127-2013

December 10, 2012

Class III

Product summary

Firm
Upsher Smith Laboratories, Inc.
Event
Event 64085
Status
Terminated
Classification
Class III
Quantity
11,316 bottles
Official record key
drug-enforcement:D-127-2013

Official wording

Reason: Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.

Code information: Lot #: 310162, Exp 09/14

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Error