Drug product
Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD
D-1317-2019
Product summary
- Firm
- Inopak Ltd
- Event
- Event 82645
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,850 pounds per batch
- Official record key
drug-enforcement:D-1317-2019
Official wording
Reason: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Code information: Batch #: 6668, 6721
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations