Proton Armor recalled over manufacturing violations

Recall date

August 15, 2022

Source

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

Official notice title

Ultra Chem Labs Corp recalls Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Saf…

Recall number

D-0017-2023

FDA classification

Class II

Brand / firm

Ultra Chem Labs Corp

Sold / distributed

Nationwide

Why it was recalled

Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.

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

What was recalled

Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.