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

FDA recall notice · announced July 11, 2012 · Ranbaxy

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot #: RB81031, Exp 01/13
Quantity: 2544 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1405-2012)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.