The Recall Desk
ModerateFDA (Drugs)·D-1591-2020·Announced 2020-09-30

Yacana Alcohol Antiseptic Recalled for cGMP Deviations in Texas

Grupo Yacana Mexico is voluntarily recalling 43,728 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 due to cGMP deviations, which typically indicates a remote probability of serious adverse health consequences or temporary/reversible effects, aligning with the 'Moderate' severity criteria for low-risk contamination or voluntary precautionary recalls without reported injuries.

Plain-English summary

Grupo Yacana Mexico SAS de CV is voluntarily recalling 43,728 bottles of Yacana Alcohol Antiseptic 70% Topical Solution, 8.5 oz (250 mL). The product is an over-the-counter topical antiseptic manufactured by Greensys of North America LLC in McAllen, Texas. The recall covers all lots of the product, identified by NDC# 76562-000-85 and UPC 6 64213 64350 0.

The recall was initiated on August 18, 2020, due to current Good Manufacturing Practice (cGMP) deviations. The FDA 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 recall was initiated by the firm and notified the public via press release.

The affected product was distributed in Texas. Consumers who have this product should stop using it and contact the recalling firm for instructions on return or disposal. The recall status is currently terminated as of May 17, 2023.

The recalled product

Product
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy Ste 100 McAllen, TX USA 78503, NDC# 76562-000-85, UPC 6 64213 64350 0
Manufacturer
GRUPO YACANA MEXICO SAS DE CV
Category
Drug — Topical Antiseptic
Hazard
Affected units
43,728

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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