Date: 03/07/2017
Product: Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
Company: A&H Focal Inc.
Recall Reason: 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.
Classification: Class I
Report Date: 20180207