Key Takeaway

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 by Ranbaxy Inc. was recalled on March 16, 2012. The hazard: Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.

FDA Drug Class III Terminated

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

Recalled: March 16, 2012 ~2544 bottles units affected D-1405-2012

Description

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 / Reason

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

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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

Drugs

Company Information

Ranbaxy Inc.

Princeton, NJ, United States

View all 9 recalls by Ranbaxy Inc. →

Distribution

Nationwide

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Frequently Asked Questions

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How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.