Class II · Moderate risk
PROBLEND Hand Sanitizer
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
7 Eleven FOR GAS ISLAND USE ONLY
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
- Recalling firm
- Seatex LLC
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0358-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Seatex LLC
All 2024 recalls
Class II · Moderate risk
7 Eleven Hand Sanitizer Gel
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
PROBLEND E3 Foaming Hand Sanitizer
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Other cgmp deviation recalls from 2024
All cgmp deviation recalls
Class II · Moderate risk
First Aid Beauty Ultra Repair Cream
CGMP Deviations; product intended for quarantine was inadvertently distributed
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
CGMP Deviations
Class II · Moderate risk
10 Irregular Pigmentation
CGMP Deviations: Inconsistency in the water systems.
Class II · Moderate risk
Henry Schein
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
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