FDA recall D-1314-2019

Inopak Ltd · Class II · drug

Product

INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, 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-1314-2019