D-0149-2018 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 10, 2018
- Initiation Date
- September 20, 2017
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 308 bottles
Product Description
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
Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.
Distribution Pattern
Florida
Code Information
All lots, Exp. 02/23/2020