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Recall Observatory FDA recall evidence

Drug product

Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446

D-1387-2012

May 21, 2012

Class II

Product summary

Firm
Kutol Products Co Inc
Event
Event 61960
Status
Terminated
Classification
Class II
Quantity
11,688 gallon bottles (2,922 cases)
Official record key
drug-enforcement:D-1387-2012

Official wording

Reason: 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.

Code 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

Distribution pattern: IL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.