FDA recall D-051-2013

Stat Rx USA · Class III · 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

Reason for recall

Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."

Distribution

GA and TN.

Key facts

Status
Terminated
Initiation date
2012-08-23
Report date
2012-11-21
Termination date
2013-01-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gainesville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-051-2013