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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