# FDA recall D-1405-2012

> **Ranbaxy Inc.** · Class III · drug recall initiated 2012-03-16.

## Product

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

## Reason for recall

Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1405-2012
- **Recalling firm:** Ranbaxy Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-03-16
- **Report date:** 2012-07-11
- **Termination date:** 2013-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1405-2012

## Citation

> AI Analytics. FDA recall D-1405-2012. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1405-2012. Source: US FDA. Licensed CC0.

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