Hand Sanitizer Recalled Nationwide for Manufacturing Practice Deficiencies
Seatex LLC is recalling PROBLEND E3 Foaming Hand Sanitizer due to manufacturing practice deviations identified during FDA inspection. The recall affects products distributed nationwide in the US and Puerto Rico.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is manufacturing-process-based rather than contamination or mislabeling with known pathogens. Per the rubric, when no harm is reported and the hazard is theoretical, the score does not exceed 3. This manufacturing deficiency without documented impact scores as Moderate.
Plain-English summary
Seatex LLC is recalling PROBLEND E3 Foaming Hand Sanitizer, an all-in-one foaming hand sanitizer and cleanser product.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. During an FDA inspection of Seatex's manufacturing facility, deficiencies were identified in the manufacturing controls and processes.
The recall affects 274 cases distributed nationwide in the United States and Puerto Rico. The affected lots are Lot #265029 (expiration date 03/27/2024) and Lot #273759 (expiration date 11/29/2024). The product was manufactured by Seatex LLC, located at 445 TX Hwy 36, Rosenberg, TX 77471.
Consumers who have purchased affected lots should discontinue use and contact the manufacturer or their retailer for instructions on product return or disposal.
The recalled product
- Product
- PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471
- Manufacturer
- Seatex LLC
- Category
- Drug — Hand Sanitizer
- Hazard
- cgmp-deviation
- manufacturing-deficiency
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 (4)
- Lot #: 265029
- Exp. 03/27/2024
- 273759
- Exp. 11/29/2024.
Distribution
Distributed nationwide across the United States.
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