Yacana Alcohol Antiseptic Recalled for cGMP Deviations in Texas
Grupo Yacana Mexico is voluntarily recalling 55,560 bottles of Yacana Alcohol Antiseptic 70% Topical Solution distributed in Texas due to current Good Manufacturing Practice (cGMP) deviations.
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 and is voluntary, initiated by the firm due to cGMP deviations. There are no reported illnesses or injuries, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
Grupo Yacana Mexico SAS de CV is voluntarily recalling 55,560 bottles of Yacana Alcohol Antiseptic 70% Topical Solution, 8.5 oz (250 mL). The product is an over-the-counter topical antiseptic manufactured in Monterrey, Nuevo Leon, Mexico. The recall was initiated on August 18, 2020, and was classified as Class II by the FDA.
The reason for the recall is current Good Manufacturing Practice (cGMP) deviations. The recall covers all lots of the product, identified by NDC # 76592-002-04 and UPC 6 03765 37699 3. The product was distributed in Texas. The recall status is terminated as of May 17, 2023.
Consumers who have this product should stop using it and contact the recalling firm for further instructions. The firm notified the public via a press release.
The recalled product
- Product
- Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Grupo Yacana Mexico SAS de CV Ave. Alfonso reyes 714 Col. Contry La Silla, Monterrey, Nuevo Leon, Mexico Tel. +52 812473-8453, NDC # 76592-002-04, UPC 6 03765 37699 3
- Manufacturer
- GRUPO YACANA MEXICO SAS DE CV
- Category
- Drug — Topical Antiseptic
- Hazard
- Affected units
- 55,560
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 GRUPO YACANA MEXICO SAS 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 · GRUPO YACANA MEXICO SAS DE CV
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FDA (Drugs) · 2020-09-30
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