FDA recall D-0357-2024

Seatex LLC · Class II · drug

Product

PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471

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-0357-2024