Inopak product recalled over manufacturing violations

Recall date

April 22, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Inopak Ltd recalls ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a)…

Recall number

D-1310-2019

FDA classification

Class II

Brand / firm

Inopak Ltd

Sold / distributed

Nationwide in the USA

Why it was recalled

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6/1000ML pouches per case, 5063-OS1000; d) INOFOAM Antibacterial Foaming Hand Wash with .3% PCMX, packaged in 1000mL pouches, 6-1000ml pouches per case, 5063-FL1000, Inopak LTD., 24 Executive Parkway, Ringwood, NJ 07456.