FDA-Drug2013-01-23Class III

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.

Upsher Smith Laboratories, Inc.
Hazard

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

Sold states
Nationwide and Puerto Rico
Affected count
11,316 bottles
Manufactured in
6701 Evenstad Drive, N/A, Maple Grove, MN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-127-2013

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