Recalls / Class III
Class IIID-1405-2012
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
- Affected lot / code info
- Lot #: RB81031, Exp 01/13
Why it was recalled
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Recalling firm
- Firm
- Ranbaxy Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 College Rd E Ste 2100, N/A, Princeton, New Jersey 08540-6636
Distribution
- Quantity
- 2544 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-03-16
- FDA classified
- 2012-07-03
- Posted by FDA
- 2012-07-11
- Terminated
- 2013-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1405-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.