Avant Foaming Hand Sanitizer recalled due to manufacturing process deviation
Aire-Master of America is recalling Avant Foaming Hand Sanitizer due to a manufacturing process deviation where the deionized water system lacked proper microbial controls during production.
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 a risk-of-harm product where a manufacturing process deviation could result in microbial contamination of the finished good. FDA Class II designation and absence of reported illnesses or injuries limits the score to High per the rubric criterion that theoretical hazards with no reported injury cap at 3.
Plain-English summary
Aire-Master of America Inc is recalling Avant Foaming Hand Sanitizer Ophardt Fragrance Free (Product Number 46076) in 1000 mL cartons because the product was manufactured using deionized water from a system that lacked appropriate microbial control post deionization, a deviation from Current Good Manufacturing Practice (CGMP) standards.
The manufacturing process deviation occurred in the water system used to produce the hand sanitizer. Deionized water without proper microbial controls could allow contamination in the finished product, potentially affecting both safety and efficacy.
Approximately 9,176 cartons were distributed to Florida, Illinois, Iowa, and New Jersey. Affected lots are 722896 (expiration 07/22) and 722996 (expiration 07/22).
Consumers who have purchased this product should discontinue use. Contact Aire-Master of America Inc or your local health department for instructions on product return or disposal.
The recalled product
- Product
- Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
- Manufacturer
- Aire-Master of America Inc
- Category
- Drug — Topical Antiseptic
- Hazard
- microbial-contamination
- cgmp-deviation
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 (2)
- Product Number 46076 Lot 722896-exp 07/22
- 722996-exp 07/22
Distribution
Distribution scope not specified by the agency.
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