A&H Focal Inc. recalls Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
Recalled February 7, 2018 · FDA recall D-0552-2018 · A&H Focal
Hazard
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. · FDA Class II
Units
unknown
Sold at
NY and NJ through six retail stores named "Asian Food Markets"
Description
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.
Product
Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
Manufacturer(s)
A&H Focal Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →