D-0359-2024 Class II Terminated
FDA drug recall D-0359-2024 was initiated by Seatex LLC on February 19, 2024 and is designated Class II. Reason for recall: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. The recall status is terminated (terminated August 15, 2025). Affected quantity: 1,282 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- March 6, 2024
- Initiation Date
- February 19, 2024
- Termination Date
- August 15, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,282 cases
Product Description
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
Reason for Recall
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Distribution Pattern
Nationwide in the US and Puerto Rico
Code Information
Lot #s: 266029, Exp. 03/27/2024; 255917, Exp. 06/23/2024; 261521, Exp. 06/27/2024.