FDAFDA · Food and drugs·Recall number D-1135-2019
LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz is labeled as LEOPARD Miracle of Honey, UPC 8 699415 912859, Manufactured in Turkey, www leopardhoneytr.com.
Published April 17, 2019 · Recall initiated: March 5, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- USA LESS Inc.
- Distributor
- Nationwide in the USA.
- Lot
- All lots
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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