FDA Recall D-0960-2016
Reesna, Inc · Canoga Park, CA
Class I — life-threatening Terminated 181 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
FUEL UP HIGH OCTANE, 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.
Recall record
- Recall number
D-0960-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Nationwide and United Kingdom
- Recall initiated
- 2015-12-11
- Classified by FDA Center
- 2016-06-06
- FDA published
- 2016-06-15
- Terminated
- 2016-06-09
- Recalling firm
- Reesna, Inc
- Firm location
- Canoga Park, CA