FDA recall D-0221-2019

Product

Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441.

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-0221-2019