Fossil Fuel Products Recalls RezzRX Capsules for Undeclared Ingredients
Fossil Fuel Products, LLC is recalling RezzRX capsules because they contain undeclared hydroxylthiohomosildenafil and aminotadalafil.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- 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.
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