Protect U Guard Foaming Hand Sanitizer Ophardt — Class II drug recall D-1358-2022
Terminated recall by Aire-Master of America Inc, reported 2022-08-24, distributed in FL, IA, IL, NJ. CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial contro
| Recall number | D-1358-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aire-Master of America Inc, Nixa, MO, United States |
| Recall initiated | 2022-07-15 |
| Classified | 2022-08-18 |
| Reported by FDA | 2022-08-24 |
| Terminated | 2023-02-19 |
| Distributed | FL, IA, IL, NJ |
| Quantity | 960 cartons |
| Reason classes | microbial contamination, cgmp |
| Lot numbers | 08/22, 722782 |
Product
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
Reason for recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1358-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.