Drug 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
D-1405-2012
Product summary
- Firm
- Ranbaxy Inc.
- Event
- Event 61934
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2544 bottles
- Official record key
drug-enforcement:D-1405-2012
Official wording
Reason: Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Code information: Lot #: RB81031, Exp 01/13
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent