The Recall Desk
ModerateFDA (Drugs)·D-1590-2020·Announced 2020-09-30

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.

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 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 →

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