FDA recall D-0220-2019

S.C. Johnson Professional · Class II · drug

Product

deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27.

Reason for recall

CGMP Deviations: Product was released to market prior to microbiological testing.

Distribution

NC

Key facts

Status
Terminated
Initiation date
2018-10-26
Report date
2018-11-14
Termination date
2020-09-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Charlotte, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0220-2019