Drug product
Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-shaking (Int'l) Cop. USA, ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA --- UPC# 8931028556885
D-0149-2018
Product summary
- Event
- Event 78073
- Status
- Terminated
- Classification
- Class I
- Quantity
- 308 bottles
- Official record key
drug-enforcement:D-0149-2018
Official wording
Reason: Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.
Code information: All lots, Exp. 02/23/2020
Distribution pattern: Florida
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.