Ranbaxy Recalls Subpotent Balnetar Therapeutic Tar Bath Coal Tar Product
Ranbaxy Inc. is recalling Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5%, because the product failed to meet specifications for coal tar content.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text identifies this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Ranbaxy Inc. is recalling 2,544 bottles of Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle. The product is distributed by Ranbaxy in Jacksonville, FL, and carries NDC 10631-106-08. The specific lot affected is RB81031 with an expiration date of 01/13.
The recall was initiated because the product is subpotent, meaning it contains less of the active ingredient than labeled. Specifically, the product yielded an out-of-specification result for the coal tar content assay. This is a Class III recall, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers who have this product should stop using it and contact Ranbaxy Inc. for further instructions or a refund. The product was distributed nationwide.
The recalled product
- 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
- Manufacturer
- Ranbaxy Inc.
- Category
- Drug — Topical
- Hazard
- Affected units
- 2,544
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: RB81031
- Exp 01/13
Distribution
Distributed nationwide across the United States.
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