FDA recall D-0016-2023

Ultra Chem Labs Corp · Class II · drug

Product

Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, 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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2022-08-15
Report date
2022-11-02
Termination date
2024-08-13
Voluntary/Mandated
N/A
Location
Ontario, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0016-2023