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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Product Detail

Product Description 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.
Recall Number D-1427-2012
Classification Class III
Code Info Lot #: 28JN1272, Exp 02/15
Product Distributed Qty 51 Bottles
Reason For Recall Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.

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 E-Mail
Distribution Pattern Nationwide