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.
Reported: January 23, 2013 Initiated: December 10, 2012 #D-127-2013
Product Description
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.
Reason for Recall
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Details
- Recalling Firm
- Upsher Smith Laboratories, Inc.
- Units Affected
- 11,316 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Upsher Smith Laboratories, Inc.. Units affected: 11,316 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 23, 2013. Severity: Low. Recall number: D-127-2013.
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