The Recall Desk
CriticalFDA (Drugs)·D-1248-2014·Announced 2014-04-30

Fossil Fuel Products Recalls RezzRX Capsules for Undeclared Ingredients

Fossil Fuel Products, LLC is recalling RezzRX capsules because they contain undeclared hydroxylthiohomosildenafil and aminotadalafil.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Fossil Fuel Products, LLC is recalling RezzRX capsules, available in single blister packs and 20-count bottles. The recall involves 50,300 capsules distributed nationwide.

The FDA is recalling these products because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the capsules contain undeclared hydroxylthiohomosildenafil and aminotadalafil.

Consumers should stop using RezzRX capsules immediately and contact the distributor for further instructions.

The recalled product

Product
RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309
Manufacturer
Fossil Fuel Products, LLC
Category
Drug — Prescription/OTC Drug
Hazard
Affected units
50,300

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lots QL110408B046
  • QL110714A102 Exp. 11/13

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · undeclared ingredients

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