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RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, ...

FDA Recall #D-1248-2014 — Class I — November 18, 2013

Recall #D-1248-2014 Date: November 18, 2013 Classification: Class I Status: Terminated

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.

Recalling Firm

Fossil Fuel Products, LLC — Dallas, GA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

50,300 capsules

Distribution

Nationwide.

Code Information

Lots QL110408B046, QL110714A102 Exp. 11/13

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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