D-0016-2023 Class II Terminated

Recalled by Ultra Chem Labs Corp — Ontario, CA

Recall Details

Product Type
Drugs
Report Date
November 2, 2022
Initiation Date
August 15, 2022
Termination Date
August 13, 2024
Voluntary/Mandated
N/A
Product Quantity
5-10 gallons

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.

Distribution Pattern

Nationwide

Code Information

Batch: 20087131. No Expiration dates Product Code: a) 3020-8 (8 oz) b) 3020-3 (32 oz) c) 3020-5 (1.7 fl oz./50 mL)