FDA recall D-0359-2024

Seatex LLC · Class II · 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

Reason for recall

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

Distribution

Nationwide in the US and Puerto Rico

Key facts

Status
Terminated
Initiation date
2024-02-19
Report date
2024-03-06
Termination date
2025-08-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rosenberg, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0359-2024