FDA Drug Recalls

Recalls / Class II

Class IID-0221-2019

Product

Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441.

Affected lot / code info
Lot 9085

Why it was recalled

CGMP Deviations: Product was released to market prior to microbiological testing.

Recalling firm

Firm
S.C. Johnson Professional
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
2815 Coliseum Centre Dr Ste 600, Charlotte, North Carolina 28217-0144

Distribution

Quantity
258 cases
Distribution pattern
NC

Timeline

Recall initiated
2018-10-26
FDA classified
2018-11-06
Posted by FDA
2018-11-14
Terminated
2020-09-08
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0221-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.