CLASS II Drug recall · Reported 2 Nov 2022 · FDA Enforcement Report
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand recalled
Ultra Chem Labs is recalling Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, distributed nationwide in the US. The recall was initiated on 15 Aug 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0017-2023
- FDA event ID
- 90973
- Recalling firm
- Ultra Chem Labs, Ontario, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Aug 2022
- FDA classified
- 21 Oct 2022
- Reported
- 2 Nov 2022
- Type
- N/A
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Hand Sanitizer
Timeline
| 15 Aug 2022 | Recall initiated by company | |
| 21 Oct 2022 | Classified by FDA | +67 days |
| 2 Nov 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Product as listed by the FDA
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, 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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Which lots are affected?
Batch 20117206. No Expiration dates Product Code: a) 3030-8 (8 oz) b) 3030-3 (32 oz) c) 3030-5 (1.7 fl oz./50 mL)
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 90973| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand recalled | Ultra Chem Labs | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Ultra Chem Labs
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand recalled | Ultra Chem Labs | Manufacturing (CGMP) Deviations | Nationwide |