Recalls / Class II
Class IID-1355-2022
Product
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
- Affected lot / code info
- [Product number], lot code, expiry: a) [46016] Lot 722770, exp 07/22 b) [46017] Lot 722995-exp 07/22, 727370-exp 07/23, 727898-exp 09/23, 728005-exp 08/23, 729522-exp12/23, 730412-exp 03/24, 730861-exp 04/24 c) [46138] Lot 725188-exp 12/22
Why it was recalled
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Recalling firm
- Firm
- Aire-Master of America Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1821 N State Highway Cc, Nixa, Missouri 65714-8015
Distribution
- Quantity
- 18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drums
- Distribution pattern
- Florida, Illinois, Iowa, New Jersey
Timeline
- Recall initiated
- 2022-07-15
- FDA classified
- 2022-08-18
- Posted by FDA
- 2022-08-24
- Terminated
- 2023-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1355-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.