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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

Soluciones Cosmeticas, SA de CV: Bersih Hand Sanitizer Gel Recalled for Manufacturing Deficiencies

Agency Publication Date: September 2, 2020
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Summary

Approximately 2.4 million bottles of Bersih Hand Sanitizer Gel (500ml) are being recalled due to deviations from Good Manufacturing Practices (cGMP). These bottles were distributed in New York and throughout the United States in containers with blue or green caps. Because these products did not meet safety and quality manufacturing standards, they may not be effective or could contain unintended ingredients.

Risk

Manufacturing deviations mean the product's safety, identity, and purity cannot be guaranteed, potentially exposing users to sub-potent or contaminated gel that may not effectively kill germs or could cause skin irritation.

What You Should Do

  1. Check your hand sanitizer bottle to see if it is Bersih Hand Sanitizer Gel in a 16.9 fluid ounce (500ml) size with either a blue or green cap.
  2. Identify the product by checking the back label for UPC 8 16822 02666 7 and distribution by RediBag USA.
  3. Examine your bottle for any lot numbers; this recall includes all lots that are currently within their expiration date.
  4. Stop using the hand sanitizer immediately and contact your healthcare provider or pharmacist if you have experienced any adverse reactions.
  5. Return any unused product to the pharmacy or place of purchase for a refund.
  6. Contact Soluciones Cosmeticas, SA de CV or your healthcare provider for further instructions regarding the disposal or return of this product.
  7. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Manufacturer refund and healthcare consultation

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

Affected Products

Product: Bersih Hand Sanitizer Gel (16.9 floz / 500ml)
Model:
Recall #: D-1560-2020
UPC Codes:
816822026667
Lot Numbers:
All lots remaining within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86042
Status: Resolved
Manufacturer: Soluciones Cosmeticas, SA de CV
Sold By: RediBag USA
Manufactured In: Mexico
Units Affected: 2,486,400 bottles
Distributed To: Nationwide

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 · 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.