FDA recall D-1405-2012

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-03-16

Report date

2012-07-11

Termination date

2013-02-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1405-2012