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Recall Observatory FDA recall evidence

Drug 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

D-0358-2024

February 19, 2024

Class II

Product summary

Firm
Seatex LLC
Event
Event 93986
Status
Terminated
Classification
Class II
Quantity
3 cases
Official record key
drug-enforcement:D-0358-2024

Official wording

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

Code information: Lot #: 251176, Exp. 06/23/2024.

Distribution pattern: Nationwide in the US and Puerto Rico

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations: deficiencies