PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: November 2, 2022 Initiated: August 15, 2022 #D-0016-2023

Product Description

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.

Details

Recalling Firm
Ultra Chem Labs Corp
Units Affected
5-10 gallons
Distribution
Nationwide
Location
Ontario, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Ultra Chem Labs Corp. Units affected: 5-10 gallons.
Why was this product recalled? ▼
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 2, 2022. Severity: Moderate. Recall number: D-0016-2023.

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