FDA recall D-0149-2018

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

Reason for recall

Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.

Distribution

Florida

Key facts

Status

Terminated

Initiation date

2017-09-20

Report date

2018-01-10

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Worth, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0149-2018