Recalls / Class II

Class IID-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.

Affected lot / code info

Lot: 220888, Exp. 05/20/2023

Why it was recalled

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

Recalling firm

Firm

Seatex LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

445 Highway 36 N, Rosenberg, Texas 77471-8756

Distribution

Quantity

2880 containers

Distribution pattern

FL, GA, TX

Timeline

Recall initiated

2023-04-19

FDA classified

2023-05-03

Posted by FDA

2023-05-10

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0562-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.