Drug product
7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033
D-0359-2024
Product summary
- Firm
- Seatex LLC
- Event
- Event 93986
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,282 cases
- Official record key
drug-enforcement:D-0359-2024
Official wording
Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Code information: Lot #s: 266029, Exp. 03/27/2024; 255917, Exp. 06/23/2024; 261521, Exp. 06/27/2024.
Distribution pattern: Nationwide in the US and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations: deficiencies