Silver Sword capsules recalled for undeclared sildenafil ingredient
Fabscout Entertainment is recalling Silver Sword capsules because FDA analysis found they contain sildenafil, an undeclared active pharmaceutical ingredient.
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 per the rubric.
Plain-English summary
Fabscout Entertainment, Inc. is recalling Silver Sword capsules, 180 mg, 16-count clamshell tins. The product is identified by UPC 1 234658 970128 12345 and features labeling in a foreign language. The recall covers all lots of the product.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Laboratory analysis conducted by the FDA determined that the capsules contain sildenafil, which is an undeclared active pharmaceutical ingredient.
The product was distributed nationwide and in France. Consumers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language)
- Manufacturer
- Fabscout Entertainment, 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 2 recalled by Fabscout Entertainment, 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 · Fabscout Entertainment, Inc
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