FDA recall D-0360-2024

Product

PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 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-0360-2024