FDA recall D-1317-2019

Product

Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD

Reason for recall

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-04-22

Report date

2019-06-05

Termination date

2024-08-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ringwood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1317-2019