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

Recall Number: D-0560-2018

Firm: A&H Focal Inc.

Classification: Class I

Status: Terminated

Report Date: 20180207

Initiation Date: 20170307

Termination Date: 20190614

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.

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