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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Detail

Product Description 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
Recall Number D-829-2013
Classification Class II
Code Info Lot Numbers: 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300 and 284300.
Product Distributed Qty A total of 133,968 bottles (units)
Reason For Recall Failed Impurity/Degradation Specification; "Related Compound C"

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 Letter
Distribution Pattern Nationwide
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