FDA Drug Recalls

Recalls / Class II

Class IID-0358-2024

Product

7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033

Affected lot / code info
Lot #: 251176, Exp. 06/23/2024.

Why it was recalled

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

Recalling firm

Firm
Seatex LLC
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
445 Highway 36 N, Rosenberg, Texas 77471-8756

Distribution

Quantity
3 cases
Distribution pattern
Nationwide in the US and Puerto Rico

Timeline

Recall initiated
2024-02-19
FDA classified
2024-02-29
Posted by FDA
2024-03-06
Terminated
2025-08-15
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0358-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.