FDA recall D-0004-2018

Inopak Ltd · Class II · drug

Product

Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ

Reason for recall

GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.

Distribution

nationwide

Key facts

Status
Terminated
Initiation date
2017-08-23
Report date
2017-10-11
Termination date
2020-04-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ringwood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0004-2018