Ultra Chem Labs Corp: Drug Recall

Recall #D-0016-2023 · 08/15/2022

Class II: Risk

Recall Details

Recall Number: D-0016-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Ultra Chem Labs Corp
Status: Terminated
Date Initiated: 08/15/2022
Location: Ontario, CA, United States
Voluntary/Mandated: N/A
Product Quantity: 5-10 gallons

Reason for Recall

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

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.

Distribution Pattern

Nationwide

Other Recalls by Ultra Chem Labs Corp

Class II: Risk 08/15/2022

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

View all recalls by Ultra Chem Labs Corp →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.