The Recall Desk
ModerateFDA (Drugs)·D-1387-2012·Announced 2012-06-27

Kutol Hands Down Medicated Lotion Soap Recalled for Unapproved Dye

Kutol Products Co Inc is recalling Hands Down Medicated Lotion Soap because it contains Red Dye #15, an ingredient not approved for use in drugs.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a labeling/undeclared additive issue without reporting specific illnesses or injuries, fitting the criteria for moderate severity.

Plain-English summary

Kutol Products Co Inc is recalling Hands Down Medicated Lotion Soap, 1 gallon bottles, distributed by PCS Industries. The recall involves 11,688 gallon bottles (2,922 cases) distributed in Illinois.

The recall was initiated because the product contains Red Dye #15, an unapproved ingredient. According to the FDA, this dye is not approved for use in food, drugs, or cosmetics.

Consumers should stop using the product and contact the recalling firm for instructions on disposal or return.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed in 1 state: