FDA-Drug2012-07-11Class III

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

Ranbaxy Inc.
Hazard

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

Sold states
Nationwide
Affected count
2544 bottles
Manufactured in
600 College Rd E Ste 2100, N/A, Princeton, NJ, United States
Products
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

Official notice

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

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