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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Product Detail

Product Description 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
Recall Number D-1405-2012
Classification Class III
Code Info Lot #: RB81031, Exp 01/13
Product Distributed Qty 2544 bottles
Reason For Recall Subpotent (single Ingredient Drug): out of specification result for coal tar content assay.

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 Letter
Distribution Pattern Nationwide
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