PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: June 5, 2019 Initiated: April 22, 2019 #D-1314-2019

Product Description

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.

Details

Recalling Firm
Inopak Ltd
Units Affected
17,850 pounds per batch
Distribution
Nationwide in the USA
Location
Ringwood, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Inopak Ltd. Units affected: 17,850 pounds per batch.
Why was this product recalled?
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 5, 2019. Severity: Moderate. Recall number: D-1314-2019.