Recalls / Class I
Class ID-1335-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO.
- Affected lot / code info
- 12 pill bottle and 3 pill bottle: Lot # B70130 Exp. 03/15; 1 pill pack: Lot # 06012011 Exp 06/14.
Why it was recalled
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Recalling firm
- Firm
- Schindele Enterprises dba Midwest Wholesale
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 617 N Althea Ave, N/A, Nixa, Missouri 65714-7432
Distribution
- Quantity
- 500 1-ct blisters; 30 3-ct bottles, 4 12-ct bottles
- Distribution pattern
- Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Timeline
- Recall initiated
- 2014-01-09
- FDA classified
- 2014-05-20
- Posted by FDA
- 2014-05-28
- Terminated
- 2015-02-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1335-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.