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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

Ata International Inc: Blue Fusion Capsules Recalled for Containing Undeclared Drug Ingredients

Agency Publication Date: March 28, 2019
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Summary

Ata International Inc is recalling all lots of Blue Fusion Capsules, a product sold in 1-count blister packs. This recall was initiated after FDA laboratory analysis confirmed the product contains several undeclared drug ingredients, including Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein. These substances are the active ingredients in FDA-approved prescription drugs for erectile dysfunction, but Blue Fusion is being marketed as a dietary supplement without an approved application. Consumers who have purchased these capsules should contact their healthcare provider or pharmacist immediately, as the product may pose serious health risks.

Risk

These undeclared ingredients can interact dangerously with nitrates found in some prescription drugs, such as nitroglycerin, potentially lowering blood pressure to life-threatening levels. This risk is particularly high for consumers with diabetes, high blood pressure, high cholesterol, or heart disease who often take nitrates.

What You Should Do

  1. Check your medicine cabinet for Blue Fusion Capsules in 1-count blister packs with UPC 7 48252 66460 0.
  2. Verify if your product was distributed by DNS Distribution (Riverside, CA) as indicated on the packaging; all lots of this product are affected by this recall.
  3. Immediately stop using any remaining Blue Fusion Capsules and contact your healthcare provider or pharmacist if you have experienced any health problems while taking this product.
  4. Return any unused capsules to the place of purchase for a refund or contact the manufacturer, Ata International Inc, for further instructions.
  5. Report any adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program either online or by calling 1-888-463-6332.
  6. For additional information or 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

💰Full Refund

Healthcare consultation and refund

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

Affected Products

Product: Blue Fusion Capsules (1-count blister pack)
Model:
Recall #: D-1085-2019
UPC Codes:
748252664600
Lot Numbers:
All lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82419
Status: Resolved
Manufacturer: Ata International Inc
Sold By: DNS Distribution
Manufactured In: United States
Units Affected: Unknown
Distributed To: Nationwide
Agency Last Updated: April 9, 2019

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 · FDA Press Release · 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.