D-1248-2014 Class I Terminated
FDA drug recall D-1248-2014 was initiated by Fossil Fuel Products, LLC on November 18, 2013 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil. The recall status is terminated (terminated May 29, 2015). Affected quantity: 50,300 capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2014
- Initiation Date
- November 18, 2013
- Termination Date
- May 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50,300 capsules
Product Description
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.
Distribution Pattern
Nationwide.
Code Information
Lots QL110408B046, QL110714A102 Exp. 11/13