Status
Terminated
Drug Enforcement D-1405-2012
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Classification
Class III
Report Date
July 11, 2012
Termination Date
February 26, 2013
Product Information
- Product 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
- Product quantity
- 2544 bottles
- Reason for recall
- Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Ranbaxy Inc.
- Address
-
600 College Rd E Ste 2100, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1405-2012
- Event ID
- 61934
- Recall initiation date
- March 16, 2012
- Center classification date
- July 3, 2012
- Code info
- Lot #: RB81031, Exp 01/13
- More code info
- —