Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: ...
FDA Recall #D-1150-2023 — Class I — August 3, 2023
Product Description
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
Reason for Recall
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.
Recalling Firm
APG SEVEN, INC — Miami, FL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
120 bottles
Distribution
Nationwide in the USA
Code Information
All lots, Expires: 01/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated