Drug Enforcement D-0358-2024

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

Status

Terminated

Classification

Class II

Report Date

March 6, 2024

Termination Date

August 15, 2025

Product Information

Product description
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
Product quantity
3 cases
Reason for recall
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide in the US and Puerto Rico

Location & Firm

Recalling firm
Seatex LLC
Address
445 Highway 36 N

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0358-2024
Event ID
93986
Recall initiation date
February 19, 2024
Center classification date
February 29, 2024
Code info
Lot #: 251176, Exp. 06/23/2024.
More code info
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