D-1405-2012 Class III Terminated
FDA drug recall D-1405-2012 was initiated by Ranbaxy Inc. on March 16, 2012 and is designated Class III. Reason for recall: Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay. The recall status is terminated (terminated February 26, 2013). Affected quantity: 2544 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 11, 2012
- Initiation Date
- March 16, 2012
- Termination Date
- February 26, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2544 bottles
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
Reason for Recall
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Distribution Pattern
Nationwide
Code Information
Lot #: RB81031, Exp 01/13