Recalls / Class III
Class IIID-127-2013
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.
- Affected lot / code info
- Lot #: 310162, Exp 09/14
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.
Recalling firm
- Firm
- Upsher Smith Laboratories, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 6701 Evenstad Drive, N/A, Maple Grove, Minnesota 55369
Distribution
- Quantity
- 11,316 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-12-10
- FDA classified
- 2013-01-16
- Posted by FDA
- 2013-01-23
- Terminated
- 2013-11-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-127-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.