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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

Asiaticon, SA de CV: V-Klean and Protz Hand Sanitizers Recalled for Manufacturing Deficiencies

Agency Publication Date: December 7, 2020
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Summary

Asiaticon, SA de CV is recalling approximately 223,000 units of V-Klean and Protz real protection hand sanitizers because they were manufactured without following Current Good Manufacturing Practices (CGMP). This lack of adherence to quality standards means the safety, purity, and effectiveness of these alcohol-based sanitizers cannot be guaranteed. Consumers should immediately stop using these products and contact their healthcare provider if they have experienced any health problems related to their use.

Risk

Failure to follow manufacturing standards can lead to products that are contaminated or do not contain the correct amount of active ingredients. This may result in ineffective sanitization or potential skin irritation and exposure to harmful impurities.

What You Should Do

  1. Check your hand sanitizer for the following brand names and sizes: V-Klean Hand Sanitizer Gel Alcohol 70% in 8.5 fl oz (250 ml), 16.9 fl oz (500 ml), or 33.8 fl oz (1000 ml) bottles; or Protz real protection Antibacterial Hand Sanitizer (70% Ethyl Alcohol) in 13.5 fl oz (400 mL) bottles.
  2. Verify the UPC codes on the packaging: for V-Klean products, look for UPC 716053704993; for Protz products, look for UPC 7503019005002 and NDC 75192-600-02.
  3. Stop using the recalled hand sanitizer immediately and dispose of it in a hazardous waste container if available, or according to local regulations.
  4. Contact your healthcare provider or pharmacist for guidance regarding any concerns about using these products.
  5. Return any unused product to the place of purchase for a refund and contact the manufacturer, Asiaticon, SA de CV, for further instructions.
  6. 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: V-Klean Hand Sanitizer Gel Alcohol 70% (8.5 fl oz / 250 ml)
UPC Codes:
716053704993
Lot Numbers:
All lots
Product: V-Klean Hand Sanitizer Gel Alcohol 70% (16.9 fl oz / 500 ml)
UPC Codes:
716053704993
Lot Numbers:
All lots
Product: V-Klean Hand Sanitizer Gel Alcohol 70% (33.8 fl oz / 1000 ml)
UPC Codes:
716053704993
Lot Numbers:
All lots
Product: Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70% (13.5 fl oz / 400 mL)
Model:
NDC: 75192-600-02
UPC Codes:
7503019005002
Lot Numbers:
All lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86327
Status: Resolved
Manufacturer: Asiaticon, SA de CV
Sold By: Safety-Med Products, Inc.
Manufactured In: Mexico
Units Affected: 2 products (111,500 units)
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.