Drug recall
Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed…
FDA recall event 61934 · Class III · Ranbaxy Inc.
Key facts
| Event ID | 61934 |
|---|---|
| Recall numbers | D-1405-2012 |
| Recalling firm | Ranbaxy Inc. |
| Product type | Drugs |
| Products | 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 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay. |
| Initiation date | Mar 16, 2012 |
| Report date | Jul 11, 2012 |
| Termination date | Feb 26, 2013 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3003476632 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: