D-051-2013 Class III Terminated
FDA drug recall D-051-2013 was initiated by Stat Rx USA on August 23, 2012 and is designated Class III. Reason for recall: Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules." The recall status is terminated (terminated January 31, 2013). Affected quantity: 5 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 21, 2012
- Initiation Date
- August 23, 2012
- Termination Date
- January 31, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 bottles
Product Description
Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30
Reason for Recall
Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
Distribution Pattern
GA and TN.
Code Information
Lot # A00984 Exp. 01/14