FDA Drug recall D-1405-2012
Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL…
- FDA Drug
- Class III
- terminated
- Published 2012-07-11
On 2012-07-11 the FDA classified a Class III recall of Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL… by Ranbaxy, citing subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1405-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-03-16 |
| Published | 2012-07-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Ranbaxy |
| Distribution | US |
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
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Identifiers
| code_info | Lot #: RB81031, Exp 01/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class III · 2013-02-20 · Ranbaxy - Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14
FDA Drug · Class III · 2013-02-20 · Ranbaxy - Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceutical…
FDA Drug · Class II · 2012-12-05 · Ranbaxy
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1405-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.