Status
Terminated
Drug Enforcement D-0016-2023
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
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Classification
Class II
Report Date
November 2, 2022
Termination Date
August 13, 2024
Product Information
- 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.
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Ultra Chem Labs Corp
- Address
-
4581 Brickell Privado St, N/A
United States - Voluntary / Mandated
- N/A
- Status date
- —
Codes & Dates
- Recall number
- D-0016-2023
- Event ID
- 90973
- Recall initiation date
- August 15, 2022
- Center classification date
- October 21, 2022
- Code info
- 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)
- More code info
- —