PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: September 6, 2023 Initiated: August 3, 2023 #D-1150-2023

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.

Details

Recalling Firm
APG SEVEN, INC
Units Affected
120 bottles
Distribution
Nationwide in the USA
Location
Miami, FL

Frequently Asked Questions

What product 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. Recalled by APG SEVEN, INC. Units affected: 120 bottles.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 6, 2023. Severity: Critical. Recall number: D-1150-2023.