Why it was recalled
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Product description
Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885
Lot numbers, UPCs & expiration codes
All lots, Expires: 01/31/2025
Where it was sold
Nationwide in the USA
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-1150-2023
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Aug 3, 2023
- FDA report date
- Sep 6, 2023
- Quantity
- 120 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- APG SEVEN, INC
Original FDA data
Every field from FDA enforcement report D-1150-2023, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 92892
- Address
- 12030 Sw 129th Ct Ste 205
- Code information
- All lots, Expires: 01/31/2025
- Postal code
- 33186-4584
- Report date
- Sep 6, 2023
- Product type
- Drugs
- Recall number
- D-1150-2023
- Classification
- Class I
- Recalling firm
- APG SEVEN, INC
- Product quantity
- 120 bottles
- Reason for recall
- Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 3, 2023
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2023