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Recall Observatory FDA recall evidence

Drug product

Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)

D-1169-2014

June 27, 2013

Class I

Product summary

Firm
Fabscout Entertainment, Inc
Event
Event 65892
Status
Terminated
Classification
Class I
Quantity
Unavailable
Official record key
drug-enforcement:D-1169-2014

Official wording

Reason: Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.

Code information: All lots

Distribution pattern: Nationwide and France

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.