PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: July 11, 2012 Initiated: March 16, 2012 #D-1405-2012

Product Description

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.

Details

Recalling Firm
Ranbaxy Inc.
Units Affected
2544 bottles
Distribution
Nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Ranbaxy Inc.. Units affected: 2544 bottles.
Why was this product recalled?
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 11, 2012. Severity: Low. Recall number: D-1405-2012.