FDA recall D-0518-2016

Steris Corp · Class II · drug

Product

Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue, St. Louis, MO 63133, Reorder # 1452-RF, NDC 0519-1452-13, UPC (01)00724995 086251.

Reason for recall

Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.

Distribution

Medical Center/Hospitals in FL, MO, and TN.

Key facts

Status
Terminated
Initiation date
2015-10-27
Report date
2015-12-16
Termination date
2016-07-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Louis, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0518-2016