Seatex product recalled over sterility concerns

Recall date

April 19, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Seatex LLC recalls Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Con…

Recall number

D-0562-2023

FDA classification

Class II

Brand / firm

Seatex LLC

Sold / distributed

FL, GA, TX

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.