FDAMarch 5, 2019drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

usa lessusa

UPCs

86994159105348699415912859

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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