FDA Drug Class III — Least Serious

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

Hazard

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

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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
Brand
Ranbaxy Inc.
UPC
Lot #: RB81031, Exp 01/13

Units Affected

2544 bottles

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