D-1135-2019 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 17, 2019
- Initiation Date
- March 5, 2019
- Termination Date
- January 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 boxes
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA.
Code Information
All lots