FDA recall D-1335-2014

Schindele Enterprises dba Midwest Wholesale · Class I · drug

Product

BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO.

Reason for recall

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

Distribution

Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

Key facts

Status: Terminated
Initiation date: 2014-01-09
Report date: 2014-05-28
Termination date: 2015-02-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Nixa, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1335-2014