A&H Focal Inc. recalls HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language

Recall date

March 7, 2017

Source

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

Recall number

D-0566-2018

FDA classification

Class I

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 I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language