Product: Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language
Reason for recall: Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Recall initiated: 20170307
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated