Fuel Up High Octane capsules recalled for undeclared sildenafil analogue
Reesna, Inc. is recalling Fuel Up High Octane capsules because they contain undeclared hydroxythiohomosildenafil, an analogue of the prescription drug Sildenafil.
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
Reesna, Inc. is recalling Fuel Up High Octane capsules in 1-count, 5-count, and 10-count packages. The products were marketed as dietary supplements but were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male erectile dysfunction. This makes the products unapproved new drugs.
The recall involves 7,250 capsules with an expiration date of 12/18. The products were distributed nationwide and in the United Kingdom.
Consumers should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
- Manufacturer
- Reesna, Inc
- Category
- Drug — Dietary Supplement
- Affected units
- 7,250
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 (1)
- Exp. 12/18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Reesna, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Reesna, Inc
See all →- CriticalFuel Up Plus capsules recalled for undeclared sildenafil analogue
FDA (Drugs) · 2016-06-15
Same hazard · undeclared drug
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