Drug product
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
D-1169-2014
Product summary
- 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
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.