May 2012 FDA Recall Drug by Kutol Products Co Inc
D-1387-2012 - Labeling

This Class II drug recall was voluntarily initiated by Kutol Products Co Inc on May 21, 2012 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in IL and the recall is currently terminated.

Recall Number: D-1387-2012

Reason for Recall
Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics.
Initiated
05-21-2012
Reported
06-27-2012
Quantity
11,688 gallon bottles (2,922 cases)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61960
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Kutol Products Co 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
IL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2012
Product Description About Product Description
Full technical description of the product.
Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446

Batch or Lot Expiration Information

Lot# : 090204012 , 090303026 , 090508009 , 090604024 , 090725030 , 090829002, 091005017 , 091223002 , 100115022 , 100316005 , 100115022 , 100316005,100329004 , 100607017 , 100730001 , 100817014 , 100921018 , 101020009, 101208003 , 101218007 , 110405009 , (L)11053105 , (L)11062811 , (L)11081805, and (L)11091206