FDA recall D-0864-2018

Inopak Ltd · Class II · drug

Product

Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ

Reason for recall

Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2018-05-16
Report date: 2018-06-20
Termination date: 2020-10-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ringwood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0864-2018