Product: Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
Reason for recall: 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.
Recall initiated: 20130627
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated