FDA recall D-1387-2012

Kutol Products Co Inc · Class II · drug

Product

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

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.

Distribution

IL

Key facts

Status
Terminated
Initiation date
2012-05-21
Report date
2012-06-27
Termination date
2012-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cincinnati, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1387-2012