Zapien Hand Sanitizer Recalled for Sub-Potent Product
GAZA is recalling Zapien Hand Sanitizer Gel due to cGMP deviations and sub-potent product from the same facility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 due to cGMP deviations and sub-potent product, which fits the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported illness.
Plain-English summary
GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION is recalling Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL). The product was manufactured by GAZA S.A. DE C.V. in Tonala, Jalisco, Mexico. The recall involves 43,875 liters of the product, with distribution limited to Texas.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. The source text indicates that the product was made at the same facility where other product was tested and found to be sub-potent. No specific lot numbers are identified, and the recall applies to all lots.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions. The FDA has classified this recall as Class II.
The recalled product
- Product
- Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03.
- Category
- Drug — Hand Sanitizer
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.
See all 2 products in this recall →Related recalls
Same manufacturer · GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
See all →- ModeratePristine Hand Sanitizer Recalled for Sub-Potent Product at Facility
FDA (Drugs) · 2021-01-20
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