Drug product
FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,
D-0760-2023
Product summary
- Firm
- Alpha Aromatics
- Event
- Event 92347
- Status
- Terminated
- Classification
- Class II
- Quantity
- 544 1 gallon bottles
- Official record key
drug-enforcement:D-0760-2023
Official wording
Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Code information: Lot: 2020-013211 and 2020-013629, No EXP date on label.
Distribution pattern: Product was distributed to one account in NC.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations