Drug 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
D-1150-2023
Product summary
- Firm
- APG SEVEN, INC
- Event
- Event 92892
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 120 bottles
- Official record key
drug-enforcement:D-1150-2023
Official wording
Reason: 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.
Code information: All lots, Expires: 01/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
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.