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Recall notice

Natural Dior LLC Dietary Supplement recalled due to Undeclared Tadalafil, USA

10 months ago source fda.gov

United States

Natural Dior LLC, is voluntarily recalling the affected lots of Vitafer-L Gold Liquid, a dietary supplement with iron and vitamins, to the consumer level. The product has been found to contain undeclared tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Products containing tadalafil cannot be marketed as dietary supplements. Vitafer-L Gold Liquid is an unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall. The product was sold nationwide via Amazon and Walmart and distributed through wholesale accounts. The product was also exported to Miami, Florida, through an importer (Laboratorio Natural Dior LLC).

Risk Statement: Consumption of products with undeclared tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.

The product is used as a state indication(s) and is packaged in 16.9 fl oz (1.06 pt) 500 mL bottles in a folding cardboard box.

Lot Numbers and Expiration Dates:
- Lot 7021-2304 – Exp. April 2025
- Lot 7017-2304 – Exp. April 2025
- Lot 7040-2305 – Exp. May 2025
- Lot 10020-2402 – Exp. February 2026
- Lot 10011-2404 – Exp. April 2026
- Lot 7695-2307 – Exp. Not specified
- Lot R6715-2303 – Exp. March 2025
- Lot 7292-2305 – Exp. May 2025
- Lot 9669-2403 – Exp. March 2025
- Lot 10060-2404 – Exp. April 2026

Consumers who have purchased this product should stop using it immediately and return it to the place of purchase for a refund.

Company name: Natural Dior LLC
Brand name: Natural Dior LLC
Product recalled: Dietary Supplement
Reason of the recall: Undeclared Tadalafil
FDA Recall date: February 26, 2025

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natural-dior-llc-issues-voluntary-nationwide-recall-vitafer-l-gold-liquid-due-presence-undeclared

#dietarysupplements #unitedstates

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