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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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Critical RiskFDA Drug
Medications & Supplements/Dietary Supplements

NSNY Distributor Inc: OrgaZEN 7000 and Ginseng Power 5000 Recalled for Undeclared Drug Ingredients

Agency Publication Date: June 28, 2021
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Summary

NSNY Distributor Inc is recalling approximately 2,999 units of Premium OrgaZEN 7000 and Ginseng Power 5000 capsules because they were found to contain undeclared sildenafil and/or tadalafil. These are the active ingredients in FDA-approved prescription drugs used to treat erectile dysfunction, but they are not listed on the packaging of these products. These products were distributed nationwide in the USA and are packaged in individual blister cards. Consumers should contact their healthcare provider or pharmacist regarding these products, as they are marketed without approved drug applications and contain hidden pharmaceutical ingredients.

Risk

The undeclared sildenafil and tadalafil can interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. This poses a significant health risk to consumers with diabetes, high blood pressure, high cholesterol, or heart disease who often take nitrates.

What You Should Do

  1. Check your supplements for Premium OrgaZEN 7000 (1-count blister card, UPC 0 40232 32555 7) or Ginseng Power 5000 (1-count blister card, UPC 0 40232 18144 3).
  2. Look for the brand names OrgaZEN 7000 and Ginseng Power 5000 on the packaging; all lots of these products are affected by this recall.
  3. Immediately stop using these products and contact your healthcare provider or pharmacist for guidance regarding any health concerns.
  4. Return any unused capsules to the place of purchase for a refund.
  5. Contact NSNY Distributor Inc at their Flushing, NY location if you have specific questions regarding this voluntary recall.
  6. For additional questions or to report a side effect, 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 refund

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

Affected Products

Product: Premium OrgaZEN 7000 capsule (1-count per blister card)
Model:
D-0641-2021
UPC Codes:
040232325557
Lot Numbers:
all lots
Product: Ginseng Power 5000 capsule (1-count per blister card)
Model:
D-0642-2021
UPC Codes:
040232181443
Lot Numbers:
all lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87712
Status: Active
Manufacturer: NSNY Distributor Inc
Sold By: Nutra Vita Co; GS Natural Co
Manufactured In: United States
Units Affected: 2 products (2600 capsules; 399 capsules)
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 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.