Zanilast+ Hand Sanitizer Recalled for Potential 1-Propanol Contamination
Nanomateriales S.A. de C.V. is recalling Zanilast+ Gel Antiseptic Hand Sanitizer due to GMP deviations that may result in the presence of 1-propanol.
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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard is a potential contamination (1-propanol) due to GMP deviations, with no reported illnesses or injuries mentioned in the source text.
Plain-English summary
Nanomateriales S.A. de C.V. is recalling Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) in 33.8 fl oz (1L) and 1 gallon (3.76L) bottles. The recall is due to Good Manufacturing Practice (GMP) deviations that create a potential for the product to contain 1-propanol.
The affected products are distributed in California, New York, and Mexico. The recall includes all lots of the product, with a total quantity of 19,440 liters of the 1L bottles and 25,917 gallons of the 1-gallon bottles. The product is distributed by Fujimura Trading S.A. DE C.V.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 531151); b) 1 gal (3.76L) (NDC 69912-008-02 UPC 2 000000 531144) bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col.…
- Manufacturer
- Nanomateriales Sa De Cv
- Category
- Drug — Antiseptic
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
Part of a larger recall action
This product is one of 2 recalled by Nanomateriales Sa De Cv 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 · Nanomateriales Sa De Cv
See all →- SevereZanilast+ Gel Antiseptic Hand Sanitizer Recalled for Potential 1-Propanol Contamination
FDA (Drugs) · 2020-09-30
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