APG SEVEN, INC recalls Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion,…

Recall date

August 3, 2023

Source

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

Recall number

D-1150-2023

FDA classification

Class I

Brand / firm

APG SEVEN, INC

Sold / distributed

Nationwide in the USA

Why it was recalled

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

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

Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885