Drug 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.
D-0221-2019
Product summary
- Event
- Event 81453
- Status
- Terminated
- Classification
- Class II
- Quantity
- 258 cases
- Official record key
drug-enforcement:D-0221-2019
Official wording
Reason: CGMP Deviations: Product was released to market prior to microbiological testing.
Code information: Lot 9085
Distribution pattern: NC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations