FDA Recall D-1248-2014
Fossil Fuel Products, LLC · Dallas, GA
Class I — life-threatening Terminated 557 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309
Reason for recall
Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.
Recall record
- Recall number
D-1248-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide.
- Recall initiated
- 2013-11-18
- Classified by FDA Center
- 2014-04-18
- FDA published
- 2014-04-30
- Terminated
- 2015-05-29
- Recalling firm
- Fossil Fuel Products, LLC
- Firm location
- Dallas, GA