Why it was recalled
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.
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
Lot numbers, UPCs & expiration codes
All lots, Exp. 02/23/2020
Where it was sold
Florida
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0149-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 20, 2017
- FDA report date
- Jan 10, 2018
- Quantity
- 308 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Natures Supplement
Original FDA data
Every field from FDA enforcement report D-0149-2018, exactly as published.
Show all FDA fields
- City
- Lake Worth
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 78073
- Address
- 2525 N Dixie Hwy
- Code information
- All lots, Exp. 02/23/2020
- Postal code
- 33460-6250
- Report date
- Jan 10, 2018
- Product type
- Drugs
- Recall number
- D-0149-2018
- Classification
- Class I
- Recalling firm
- Natures Supplement
- Product quantity
- 308 bottles
- Termination date
- May 1, 2019
- Reason for recall
- Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Florida
- Recall initiation date
- Sep 20, 2017
- Initial firm notification
- Press Release
- Center classification date
- Jan 4, 2018