7 Eleven Hand Sanitizer Gel recalled for manufacturing facility deficiencies
Seatex LLC is recalling 1,282 cases of 7 Eleven Hand Sanitizer Gel due to manufacturing facility deficiencies found during FDA inspection. The product was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall due to manufacturing facility deficiencies in a pharmaceutical product. No illnesses or injuries have been reported. The hazard is a manufacturing process defect in a safety-critical product, matching the rubric criterion for risk-of-harm products without reported harm.
Plain-English summary
Seatex LLC is recalling 7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic with Mountain Spring Scent. The recall includes 1,282 cases of 1250 mL product distributed nationwide in the US and Puerto Rico. The affected lots are: 266029 (Exp. 03/27/2024), 255917 (Exp. 06/23/2024), and 261521 (Exp. 06/27/2024).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection of Seatex's manufacturing facility. CGMP violations in pharmaceutical manufacturing indicate deficiencies in the production process that could affect product quality and safety.
Consumers who have purchased affected lots should stop using the product. For additional information about the recall, consult the FDA's drug recalls page or the specific recall notice (D-0359-2024).
The recalled product
- 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
- Manufacturer
- Seatex LLC
- Hazard
- manufacturing-defect
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #s: 266029
- Exp. 03/27/2024
- 255917
- Exp. 06/23/2024
- 261521
- Exp. 06/27/2024.
Distribution
Distributed nationwide across the United States.
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