Hand Sanitizer Recalled for Inadequate Microbial Control in Manufacturing
Aire-Master of America Inc is recalling Common Sense Fragrance Free Hand Sanitizer due to a manufacturing process deviation. The product was made using deionized water from a system that lacked appropriate microbial control.
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: FDA Class II recall involving a manufacturing process deviation where deionized water from a system lacking appropriate microbial control was used. This creates potential risk of microbial contamination in a product designed for sanitation purposes.
Plain-English summary
Aire-Master of America Inc is recalling Common Sense Fragrance Free Hand Sanitizer in 250-gallon totes due to a manufacturing process deviation. The recalled product includes lot numbers 724640 (expiration 11/22) and 729955 (expiration 01/24), with 4 totes identified in this recall.
The product was manufactured using deionized water from a system that lacked appropriate microbial control measures following the deionization process. This represents a deviation from current good manufacturing practices (CGMP) for pharmaceutical production.
The recalled product was distributed to customers in Florida, Illinois, Iowa, and New Jersey.
Businesses and consumers with the recalled product should discontinue use and contact Aire-Master of America Inc for further instructions or disposal guidance.
The recalled product
- Product
- Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
- Manufacturer
- Aire-Master of America Inc
- Category
- Drug — Hand Sanitizer
- Hazard
- microbial-contamination
- 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 (3)
- Product Number 46137
- Lot 724640-exp 11/22
- 729955-exp 01/24
Distribution
Distribution scope not specified by the agency.
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