Reported Jan 23, 2013 · Terminated
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only,…
Upsher Smith Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Upsher Smith Laboratories, Inc. · 6701 Evenstad Drive · Maple Grove, MN · 55369
Is this the product you have?
- 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 codes and dates
Lot #: 310162Exp 09/14
- Amount recalled
- 11,316 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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