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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

GRUPO YACANA MEXICO SAS DE CV: Alcohol Antiseptic Solution Recalled for Manufacturing Quality Deviations

Agency Publication Date: October 6, 2020
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Summary

Approximately 99,288 bottles of Yacana Alcohol Antiseptic 70% Topical Solution (8.5 oz / 250 mL) are being recalled due to significant manufacturing quality issues known as Current Good Manufacturing Practice (cGMP) deviations. This voluntary recall affects two different versions of the hand sanitizer: one manufactured by Grupo Yacana Mexico SAS de CV and another manufactured by Greensys of North America LLC. Consumers should check their bottles for specific NDC and UPC codes to see if they are affected. You should contact your healthcare provider or pharmacist for guidance regarding any concerns, and return the product to the place of purchase for a refund.

Risk

Failure to follow standard manufacturing quality practices can result in products that are ineffective or contaminated, potentially leading to skin irritation or infections when used as intended on the skin.

What You Should Do

  1. Check your bottle to see if you have Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL) with NDC # 76592-002-04 and UPC 6 03765 37699 3 (Manufactured by Grupo Yacana Mexico). All lots are affected.
  2. Check your bottle to see if you have Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL) with NDC# 76562-000-85 and UPC 6 64213 64350 0 (Manufactured by Greensys of North America). All lots are affected.
  3. Contact your healthcare provider or pharmacist for guidance if you have experienced any adverse reactions or have concerns about the product.
  4. Return any unused product to the pharmacy or place of purchase for a refund and contact the manufacturer for further instructions by calling +52 812473-8453.
  5. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Yacana Alcohol Antiseptic 70% Topical Solution (8.5 oz / 250 mL)
Model:
NDC 76592-002-04
UPC Codes:
603765376993
Lot Numbers:
All lots
Product: Yacana Alcohol Antiseptic 70% Topical Solution (8.5 oz / 250 mL)
Model:
NDC 76562-000-85
UPC Codes:
664213643500
Lot Numbers:
All lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86271
Status: Resolved
Manufacturer: GRUPO YACANA MEXICO SAS DE CV
Manufactured In: Mexico, USA
Units Affected: 2 products (55,560 bottles; 43,728 bottles)
Distributed To: Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.