Aire-Master of America Inc: Drug Recall
Recall #D-1357-2022 · 07/15/2022
Class II: Risk
Recall Details
- Recall Number
- D-1357-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Aire-Master of America Inc
- Status
- Terminated
- Date Initiated
- 07/15/2022
- Location
- Nixa, MO, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,632 cartons
Reason for Recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Product Description
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
Distribution Pattern
Florida, Illinois, Iowa, New Jersey
Other Recalls by Aire-Master of America Inc
- Class II: Risk 07/15/2022
- Class II: Risk 07/15/2022
- Class II: Risk 07/15/2022
- Class II: Risk 07/15/2022
- Class II: Risk 07/15/2022
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.