FDA Drug Recalls

Recalls / Class II

Class IID-1360-2022

Product

Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734

Affected lot / code info
Product Number 46137, Lot 724640-exp 11/22, 729955-exp 01/24

Why it was recalled

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

Recalling firm

Firm
Aire-Master of America Inc
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1821 N State Highway Cc, Nixa, Missouri 65714-8015

Distribution

Quantity
4 totes
Distribution pattern
Florida, Illinois, Iowa, New Jersey

Timeline

Recall initiated
2022-07-15
FDA classified
2022-08-18
Posted by FDA
2022-08-24
Terminated
2023-02-19
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1360-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls