Recalls / Class II
Class IID-1356-2022
Product
Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
- Affected lot / code info
- Product Number 46076 Lot 722896-exp 07/22, 722996-exp 07/22
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
- 9,176 cartons
- 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-1356-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.