Drug product
Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562.
D-0338-2024
Product summary
- Firm
- Alpha Aromatics
- Event
- Event 93880
- Status
- Terminated
- Classification
- Class II
- Quantity
- 676 gallons
- Official record key
drug-enforcement:D-0338-2024
Official wording
Reason: CGMP Deviations
Code information: Lot # 2022-012884 Lot # 2023-002020 Lot # 2023-003532 Lot # 2023-003761
Distribution pattern: Product was distributed to two accounts in NC and MI
Derived failure modes
-
Manufacturing or process control
CGMP Deviations