D-0016-2023 Class II Terminated
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)