Drug product
Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.
D-0264-2023
Product summary
- Event
- Event 91576
- Status
- Terminated
- Classification
- Class II
- Quantity
- 609 bottles
- Official record key
drug-enforcement:D-0264-2023
Official wording
Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Code information: All lots within expiry
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations