FDA Recall D-0149-2018
Natures Supplement · Lake Worth, FL
Class I — life-threatening Terminated 588 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0149-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Florida
- Recall initiated
- 2017-09-20
- Classified by FDA Center
- 2018-01-04
- FDA published
- 2018-01-10
- Terminated
- 2019-05-01
- Recalling firm
- Natures Supplement
- Firm location
- Lake Worth, FL