FDA Drug Recalls

Recalls / Class II

Class IID-0359-2024

Product

7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033

Affected lot / code info
Lot #s: 266029, Exp. 03/27/2024; 255917, Exp. 06/23/2024; 261521, Exp. 06/27/2024.

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
1,282 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-0359-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.