Seatex LLC: Drug Recall

Recall #D-0562-2023 · 04/19/2023

Class II: Risk

Recall Details

Recall Number: D-0562-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Seatex LLC
Status: Ongoing
Date Initiated: 04/19/2023
Location: Rosenberg, TX, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2880 containers

Reason for Recall

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

Product Description

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.

Distribution Pattern

FL, GA, TX

Other Recalls by Seatex LLC

Class II: Risk 02/19/2024

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II: Risk 02/19/2024

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II: Risk 02/19/2024

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II: Risk 02/19/2024

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II: Risk 02/19/2024

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

View all recalls by Seatex LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.