Clalis capsules recalled for undeclared sildenafil ingredient
Fabscout Entertainment, Inc. is recalling Clalis 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 according to the rubric.
Plain-English summary
Fabscout Entertainment, Inc. is recalling Clalis capsules, 50 mg, 6-count bottles. The product labeling is in a foreign language. The recall covers all lots of the product.
The recall is being conducted because the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Laboratory analysis 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
- Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
- Manufacturer
- Fabscout Entertainment, Inc
- Category
- Drug — Prescription Drug
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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