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
FDA recall notice · announced September 6, 2023 · Apg Seven
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
The product
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.
Notes
Distribution: Nationwide in the USA
Lot/code information: All lots, Expires: 01/31/2025
Quantity: 120 bottles
Status: Ongoing
Products in this recall event:
- 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 (D-1150-2023)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.