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
Product summary
- 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
Labeling: Label Error