FDA recall D-1135-2019

USA LESS Inc. · Class I · drug

Product

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

Nationwide in the USA.

Key facts

Status
Terminated
Initiation date
2019-03-05
Report date
2019-04-17
Termination date
2024-01-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brooklyn, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1135-2019