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

Recall Number: D-1169-2014

Firm: Fabscout Entertainment, Inc

Classification: Class I

Status: Terminated

Report Date: 20140326

Initiation Date: 20130627

Termination Date: 20191002

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.

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