FDA recall D-0102-2017

SOS Telecom Inc. · Class I · drug

Product

Ninja-X, 4200 mg, 1 capsule per pack, 24 single packs per box.

Reason for recall

Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements

Distribution

NY

Key facts

Status
Terminated
Initiation date
2016-05-12
Report date
2016-10-26
Termination date
2018-07-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bayside, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0102-2017