Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
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.
What was recalled
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
- Recalling firm
- Fabscout Entertainment, Inc
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1169-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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