FDA recall D-0220-2017

Product

BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.

Reason for recall

Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-04-29

Report date

2016-12-28

Termination date

2020-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Corpus Christi, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0220-2017