March 2012 FDA Recall Drug by Ranbaxy Inc. (D-1405-2012 - Subpotent (Single Ingredient Drug))

This Class III drug recall was voluntarily initiated by Ranbaxy Inc. on March 16, 2012 for the product Drug. The FDA reported the reason for recall as subpotent (single ingredient drug). The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1405-2012

Reason for Recall
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Initiated
03-16-2012
Reported
07-11-2012
Quantity
2544 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61934
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ranbaxy Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-26-2013
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : RB81031, Exp 01/13