Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels
Summary
The FDA issued a Class II for Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% o by Ultra Chem Labs Corp. Reason: Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process..
Details
Source
Drug Recall
External ID
D-0016-2023
Action Date
2022-11-02
Status
Terminated
Category
drug
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.
Lot/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)
Quantity Affected: 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.
Distribution
Nationwide
Type: N/A
Recall Initiated: 2022-08-15
Company
Ontario, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 39 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Ultra Chem Labs Corp has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ultra Chem Labs Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ultra Chem Labs Corp have FDA actions?
Ultra Chem Labs Corp has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0016-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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