Drug product
Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML) bottles, d)12 FL OZ (355 ML) bottles, e)16 FL OZ (473 ML) bottles, f) 64 FL OZ (1892 ML) bottles, g) 128 FL OZ (3785 ML) bottles
D-0263-2023
Product summary
- Event
- Event 91576
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 239 bottles, b) 6,352 bottles, c)14,963 bottles, d) 8,117 bottles, e)22 bottles, f)856 bottles, g) 707 bottles
- Official record key
drug-enforcement:D-0263-2023
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