FDA recall D-1036-2020

Med Man Distribution, Inc. · Class I · drug

Product

UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com.

Reason for recall

Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2019-11-08
Report date
2020-03-25
Termination date
2023-10-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pickerel, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1036-2020