The Recall Desk
CriticalFDA (Drugs)·D-1170-2014·Announced 2014-03-26

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.

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 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)

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 →

Same manufacturer · Fabscout Entertainment, Inc

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