FDAClass IIIJuly 11, 2012

Balnetar Therapeutic Tar Bath recall: Subpotent

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

Why was Balnetar Therapeutic Tar Bath recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: RB81031, Exp 01/13

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
Recalling firm
Ranbaxy Inc.
Quantity
2544 bottles
Distribution
Nationwide
Recall date
July 11, 2012
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls