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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Event Detail

Event ID 63659
Product Type Drugs
Status Ongoing
Recalling Firm Stat Rx USA
City Gainesville
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-23
Initial Firm Notification of
Consignee or Public
Distribution Pattern GA and TN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30 Lot # A00984 Exp. 01/14 Class III Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules." 5 bottles D-051-2013