Key Takeaway

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 by Aire-Master of America Inc was recalled on July 15, 2022. The hazard: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

FDA Drug Class II Terminated

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

Recalled: July 15, 2022 ~4,632 cartons units affected D-1357-2022

Description

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

Hazard / Reason

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Drugs

Company Information

Aire-Master of America Inc

Nixa, MO, United States

View all 6 recalls by Aire-Master of America Inc →

Distribution

Florida, Illinois, Iowa, New Jersey

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Frequently Asked Questions

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Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.