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

Firm: Ranbaxy Inc.

Classification: Class III

Status: Terminated

Report Date: 20120711

Initiation Date: 20120316

Termination Date: 20130226

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

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