FDA recall D-0562-2023

Product

Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471.

Reason for recall

Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications

Distribution

FL, GA, TX

Key facts

Status

Ongoing

Initiation date

2023-04-19

Report date

2023-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rosenberg, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0562-2023