Drug product

RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309

D-1248-2014

November 18, 2013

Class I

Product summary

Firm: Fossil Fuel Products, LLC
Event: Event 66878
Status: Terminated
Classification: Class I
Quantity: 50,300 capsules
Official record key: drug-enforcement:D-1248-2014

Official wording

Reason: Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.

Code information: Lots QL110408B046, QL110714A102 Exp. 11/13

Distribution pattern: Nationwide.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.