FDA Drug recall D-0016-2023
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 H…
- FDA Drug
- Class II
- terminated
- Published 2022-11-02
On 2022-11-02 the FDA classified a Class II recall of Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 H… by Ultra Chem Labs, citing chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0016-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-08-15 |
| Published | 2022-11-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ultra Chem Labs |
| Distribution | US |
Product
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
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Identifiers
| 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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0016-2023%22
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