Sani-Guard-SF Waterless Foam 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 Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000,…

Recall number

D-1317-2019

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

Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD