LEOPARD Miracle Honey packaged in a wooden box recalled over undeclared sildenafil

Recall date

March 5, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

USA LESS Inc. recalls LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sach…

Recall number

D-1135-2019

FDA classification

Class I

Brand / firm

USA LESS Inc.

Sold / distributed

Nationwide in the USA.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.