Pristine Hand Sanitizer Recalled for Sub-Potent Product at Facility
GAZA Proveedora de Servicios de Hospedaje y Alimentos is recalling Pristine Hand Sanitizer Gel due to cGMP deviations and sub-potent product at the manufacturing facility.
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: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) when no specific injuries or illnesses are reported and the hazard is related to manufacturing deviations (sub-potency) rather than acute toxicity or infection.
Plain-English summary
GAZA Proveedora de Servicios de Hospedaje y Alimentos S.A. de C.V. is recalling Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle. The product is distributed by Universal Distributors LLC in Tempe, Arizona, and was manufactured in Mexico. The recall involves 26,000 liters of the product, with distribution reported in Texas.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Specifically, the product was made at the same facility where other product tested was found to be sub-potent. Sub-potent products contain less of the active ingredient than labeled, which may reduce their effectiveness.
Consumers who have purchased this product should stop using it and contact the distributor or manufacturer for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5,
- Category
- Drug — Hand Sanitizer
- Hazard
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 (1)
- All Lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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