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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 65338
Product Type Drugs
Status Ongoing
Recalling Firm Actavis South Atlantic LLC
City Sunrise
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-15
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA Lot Numbers: 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300 and 284300. Class II Failed Impurity/Degradation Specification; "Related Compound C" A total of 133,968 bottles (units) D-829-2013