Drug recall
BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1…
FDA recall event 67228 · Class I · Schindele Enterprises dba Midwest Wholesale
Key facts
| Event ID | 67228 |
|---|---|
| Recall numbers | D-1334-2014, D-1335-2014, D-1336-2014, D-1337-2014, D-1338-2014, D-1339-2014, D-1340-2014 |
| Recalling firm | Schindele Enterprises dba Midwest Wholesale |
| Product type | Drugs |
| Products | BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO., ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA., Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured For: BTQ Ski, Inc., Chicago, IL 60638, MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA., SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY. and 2 more |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. |
| Initiation date | Jan 9, 2014 |
| Report date | May 28, 2014 |
| Termination date | Feb 3, 2015 |
| City | Nixa |
| State | MO |
| Country | United States |
| FEI number | 3010346131 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: