Aire-Master of America Inc: Drug Recall
Recall #D-1355-2022 · 07/15/2022
Class II: Risk
Recall Details
- Recall Number
- D-1355-2022
- 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
- 18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drums
Reason for Recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Product Description
Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253
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.