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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Event Detail

Event ID 62639
Product Type Drugs
Status Ongoing
Recalling Firm Stat Rx USA
City Gainesville
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-23
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90. Lot #: 28JN1272, Exp 02/15 Class III Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label. 51 Bottles D-1427-2012