US Drug Recall Register
Class III · Low risk Terminated Initiated Mar 16, 2012 (14 years ago)

Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What 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

Recalling firm
Ranbaxy Inc.
NDC code
10631-106-08
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1405-2012

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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