Recall Enforment Report D-0221-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by S.C. Johnson Professional, originally initiated on 10-26-2018 for the 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. The product was recalled due to cgmp deviations: product was released to market prior to microbiological testing.. The product was distributed in Nc and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0221-201910-26-201811-14-2018Class II258 casesAlcohol 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.CGMP Deviations: Product was released to market prior to microbiological testing.Terminated
D-0220-201910-26-201811-14-2018Class II869 casesdeb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27.CGMP Deviations: Product was released to market prior to microbiological testing.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
11084-010Refresh Antibac Foam Benzalkonium ChlorideSoapTopicalSc Johnson Professional Usa, Inc.Human Otc Drug