Avant Foaming Hand Sanitizer Recalled Due to Manufacturing Process Deviation
Aire-Master of America Inc. is recalling Avant Foaming Hand Sanitizer because the deionized water system used in manufacturing lacked appropriate microbial control measures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall due to a manufacturing process deviation that compromised microbial control in the production water system. The hazard is theoretical—potential microbial contamination rather than confirmed contamination—and no illnesses or injuries have been reported.
Plain-English summary
Avant Foaming Hand Sanitizer, 62% ethanol, is being recalled by Aire-Master of America Inc. The product is available in three package sizes: 18 fl. oz. bottles, 1000 mL pouches, and 55-gallon drums. It was manufactured for B4 Brands in Lisbon, Iowa.
The recall was issued because the product was manufactured using deionized water from a system that lacked appropriate microbial control measures after the deionization process. This manufacturing process deviation raises the potential for microbial contamination.
The recalled product was distributed to Florida, Illinois, Iowa, and New Jersey. The affected quantities are approximately 11,435 bottles, 4,116 pouches, and 2 drums.
This Class II recall was issued by the FDA due to manufacturing process deviations involving inadequate microbial control of the deionized water system used in production.
The recalled product
- 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
- Manufacturer
- Aire-Master of America Inc
- Category
- Drug — Hand Sanitizer
- Hazard
- microbial-contamination-risk
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- [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
Distribution
Distribution scope not specified by the agency.
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