Stage 2-Ophardt Foaming Hand Sanitizer Recalled Due to Microbial Control Deviation
Aire-Master of America Inc is recalling 4,632 cartons of Stage 2-Ophardt Foaming Hand Sanitizer due to manufacturing deviations in the water system's microbial control. Product was distributed in Florida, Illinois, Iowa, and New Jersey.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—potential microbial contamination resulting from a manufacturing process deviation—not confirmed contamination. This qualifies as a precautionary recall.
Plain-English summary
Aire-Master of America Inc is recalling approximately 4,632 cartons of Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL bottles, manufactured for 2XL Corporation.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The product was manufactured using deionized water from a system that lacked appropriate microbial control measures following the deionization process. This creates a potential for microbial contamination in the hand sanitizer.
The recalled product was distributed in Florida, Illinois, Iowa, and New Jersey. Affected product includes Lot 722712 (expiration 07/22), Lot 724755 (expiration 11/22), and Lot 725054 (expiration 12/22), with Product Number 46101.
The recalled product
- Product
- Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
- Manufacturer
- Aire-Master of America Inc
- Category
- Drug — Hand Sanitizer
- Hazard
- microbial-contamination
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 (4)
- Product Number 46101
- Lots 722712-exp 07/22
- 724755-exp 11/22
- 725054-exp 12/22
Distribution
Distribution scope not specified by the agency.
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