CLASS II Drug recall · Reported 24 Aug 2022 · FDA Enforcement Report
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free recalled
Aire-Master of America is recalling Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free per, distributed in Florida, Iowa, Illinois, New Jersey. The recall was initiated on 15 Jul 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-1357-2022
- FDA event ID
- 90644
- Recalling firm
- Aire-Master of America, Nixa, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jul 2022
- FDA classified
- 18 Aug 2022
- Reported
- 24 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Hand Sanitizer
Timeline
| 15 Jul 2022 | Recall initiated by company | |
| 18 Aug 2022 | Classified by FDA | +34 days |
| 24 Aug 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Product as listed by the FDA
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
Where it was distributed
Florida, Illinois, Iowa, New Jersey
Questions about this recall
Why was it recalled?
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Which lots are affected?
Product Number 46101, Lots 722712-exp 07/22, 724755-exp 11/22, 725054-exp 12/22
Where was it sold?
Florida, Illinois, Iowa, New Jersey
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
5 other products · FDA event 90644This product is part of a recall event; the main page for the event is Common Sense Fragrance Free Hand Sanitizer Tote recalled.