D-0959-2016 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2016
- Initiation Date
- December 11, 2015
- Termination Date
- June 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,250 capsules
Product Description
FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
Reason for Recall
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
Distribution Pattern
Nationwide and United Kingdom
Code Information
Exp. 12/18