Drug product
deb 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.
D-0220-2019
Product summary
- Event
- Event 81453
- Status
- Terminated
- Classification
- Class II
- Quantity
- 869 cases
- Official record key
drug-enforcement:D-0220-2019
Official wording
Reason: CGMP Deviations: Product was released to market prior to microbiological testing.
Code information: Lot 9131
Distribution pattern: NC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations