FDA Drug recall D-1357-2022
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct,…
- FDA Drug
- Class II
- terminated
- Published 2022-08-24
On 2022-08-24 the FDA classified a Class II recall of Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct,… by Aire Master, citing CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1357-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-07-15 |
| Published | 2022-08-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aire Master |
| Distribution | FL, IA, IL, NJ |
Product
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
Reason
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Identifiers
| code_info | Product Number 46101, Lots 722712-exp 07/22, 724755-exp 11/22, 725054-exp 12/22 |
|---|
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-1357-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.