D-1405-2012 Class III Terminated

Recalled by Ranbaxy Inc. — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
July 11, 2012
Initiation Date
March 16, 2012
Termination Date
February 26, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2544 bottles

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.

Distribution Pattern

Nationwide

Code Information

Lot #: RB81031, Exp 01/13