FDA recall D-0662-2021

Product

Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860

Reason for recall

Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2021-03-30

Report date

2021-07-28

Termination date

2022-06-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Palisades Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0662-2021