AQUACIL instant foaming hand sanitizer recalled over manufacturing violations

Recall date

April 22, 2019

Source

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

Official notice title

Inopak Ltd recalls AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ…

Recall number

D-1311-2019

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

AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris Pharmaceuticals (Division of Inopak).