Drug Enforcement D-051-2013

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

Status

Terminated

Classification

Class III

Report Date

November 21, 2012

Termination Date

January 31, 2013

Product Information

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
Product quantity
5 bottles
Reason for recall
Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
Recall initiation reason
Initial firm notification
E-Mail
Distribution pattern
GA and TN.

Location & Firm

Recalling firm
Stat Rx USA
Address
2481 Hilton Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-051-2013
Event ID
63659
Recall initiation date
August 23, 2012
Center classification date
November 9, 2012
Code info
Lot # A00984 Exp. 01/14
More code info