APG SEVEN, INC: Drug Recall

Recall #D-1150-2023 · 08/03/2023

Class I: Dangerous

Recall Details

Recall Number
D-1150-2023
Classification
Class I
Product Type
Drug
Recalling Firm
APG SEVEN, INC
Status
Ongoing
Date Initiated
08/03/2023
Location
Miami, FL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
120 bottles

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.

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

Distribution Pattern

Nationwide in the USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.