Gadget Island Recalls FIFTY SHADES 6000 Capsules for Undeclared Ingredients
Gadget Island, Inc. is recalling FIFTY SHADES 6000 capsules because they contain undeclared active pharmaceutical ingredients sildenafil, desmethyl carbodenafil, and tadalafil.
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
Gadget Island, Inc. is recalling FIFTY SHADES 6000 capsules, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading. The product is identified by UPC 4026666146056. The recall involves 273 1-capsule packets and affects all lots.
The recall is being conducted because the product was marketed without an Approved NDA/ANDA and contains undeclared Active Pharmaceutical Ingredients: sildenafil, desmethyl carbodenafil, and tadalafil. These ingredients are not listed on the product label.
The product was distributed nationwide in the USA. Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056
- Manufacturer
- Gadget Island, Inc
- Category
- Drug — Supplement
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)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Gadget Island, 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.
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