A&H Focal Inc. recalls Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language

Recall date

March 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0552-2018

FDA classification

Class II

Brand / firm

A&H Focal Inc.

Sold / distributed

NY and NJ through six retail stores named "Asian Food Markets"

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language