FDA recall D-0572-2018

Product

Tiger King tablets, labeling is in foreign language

Reason for recall

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Distribution

NY and NJ through six retail stores named "Asian Food Markets"

Key facts

Status

Terminated

Initiation date

2017-03-07

Report date

2018-02-07

Termination date

2019-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Staten Island, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0572-2018