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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Event Detail

Event ID 61934
Product Type Drugs
Status Ongoing
Recalling Firm Ranbaxy Inc.
City Princeton
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-16
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08 Lot #: RB81031, Exp 01/13 Class III Subpotent (single Ingredient Drug): out of specification result for coal tar content assay. 2544 bottles D-1405-2012