Zanilast+ Gel Antiseptic Hand Sanitizer Recalled for Potential 1-Propanol Contamination
Nanomateriales S.A. de C.V. is recalling 1,000 kg of 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when there are no reported hospitalizations or fatalities that would elevate the score to 5.
Plain-English summary
Nanomateriales S.A. de C.V. is recalling 1,000 kg of Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) packaged in 25 kg bottles. The product is identified by NDC 69912-006-01 and is distributed by Fujimura Trading S.A. DE C.V. in Monterrey, Mexico. The recall covers all lots of the product.
The recall was initiated due to Good Manufacturing Practice (GMP) deviations that create a potential for the product to contain 1-propanol. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected product was distributed in California, New York, and Mexico. Consumers who have purchased this product should stop using it and contact the distributor or manufacturer for further instructions.
The recalled product
- Product
- Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V. NDC 69912-006-01
- 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 →- ModerateZanilast+ Hand Sanitizer Recalled for Potential 1-Propanol Contamination
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