Drug product
Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon Technologies International 8810 Commodity Circle STE 22-23, Orlando, FL 32819, UPC 6 96952 12904 5
D-0001-2023
Product summary
- Event
- Event 90874
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1656 bottles
- Official record key
drug-enforcement:D-0001-2023
Official wording
Reason: GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Code information: Lot #: 20-018 Exp. 4/3/2023
Distribution pattern: FL and WA only
Derived failure modes
-
Manufacturing or process control
GMP Deviations