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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Event Detail

Event ID 61960
Product Type Drugs
Status Ongoing
Recalling Firm Kutol Products Co Inc
City Cincinnati
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-21
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern IL

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446 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 Class II 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. 11,688 gallon bottles (2,922 cases) D-1387-2012
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