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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

GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION: Pristine and Zapien Hand Sanitizers Recalled for Sub-potent Ingredients

Agency Publication Date: January 14, 2021
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Summary

Approximately 69,875 liters of Pristine gel and Zapien Productos Hand Sanitizer Gel are being recalled because they were manufactured at a facility that produced sub-potent batches. These products may not contain the required amount of active antibacterial ingredients necessary to effectively kill germs. This voluntary recall includes both 8.45-ounce and 33.8-ounce bottles distributed across Texas and manufactured by Gaza S.A. DE C.V.

Risk

Sub-potent hand sanitizer contains lower levels of active ingredients than promised on the label, which means it may fail to effectively kill harmful bacteria or viruses on the skin, increasing the user's risk of infection.

What You Should Do

  1. Check your product labels for Pristine gel Hand Sanitizer Gel (8.45 Fl. Oz. / 250 mL) with UPC 8 64972 00049 5 and NDC 76540-100-02, or Zapien Productos Hand Sanitizer Gel (33.8 FL. OZ / 1000 mL) with UPC 7 501700 623504 and NDC numbers 76938-001-01, 76938-001-02, or 76938-001-03.
  2. Verify if your product is affected; this recall applies to All Lots of the hand sanitizers mentioned above.
  3. Immediately stop using these hand sanitizers and contact your healthcare provider or pharmacist if you have concerns about infections or the effectiveness of the product.
  4. Return any unused product to the place of purchase for a full refund or contact the manufacturer, GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION, for further instructions.
  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

Drug product recall remedy

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

Affected Products

Product: Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing (8.45 Fl. Oz. / 250 mL)
Model:
NDC 76540-100-02
Recall #: D-0229-2021
UPC Codes:
864972000495
Lot Numbers:
All Lots
Product: Zapien Productos Hand Sanitizer Gel Antibacterial (33.8 FL. OZ / 1000 mL)
Model:
NDC 76938-001-01
NDC 76938-001-02
NDC 76938-001-03
Recall #: D-0230-2021
UPC Codes:
7501700623504
Lot Numbers:
All Lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86898
Status: Active
Manufacturer: GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION
Sold By: Universal Distributors LLC
Manufactured In: Mexico
Units Affected: 2 products (26,000 liters; 43875 liters)
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.