FDA recall D-0002-2018

Inopak Ltd · Class II · drug

Product

Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02

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-0002-2018