Drug product
Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30
D-051-2013
Product summary
- Firm
- Stat Rx USA
- Event
- Event 63659
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5 bottles
- Official record key
drug-enforcement:D-051-2013
Official wording
Reason: Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
Code information: Lot # A00984 Exp. 01/14
Distribution pattern: GA and TN.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up