Why it was recalled
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Product description
5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
Lot numbers, UPCs & expiration codes
All lots within expiry
Where it was sold
Product was sold over the internet
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-0388-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 8, 2019
- FDA report date
- Jan 30, 2019
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Happy Together, Inc.
Original FDA data
Every field from FDA enforcement report D-0388-2019, exactly as published.
Show all FDA fields
- City
- Boynton Beach
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 81913
- Address
- 1060 Audace Ave Apt 106
- Code information
- All lots within expiry
- Postal code
- 33426-3346
- Report date
- Jan 30, 2019
- Product type
- Drugs
- Recall number
- D-0388-2019
- Classification
- Class I
- Recalling firm
- Happy Together, Inc.
- Termination date
- Oct 26, 2021
- Reason for recall
- Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
- Distribution pattern
- Product was sold over the internet
- Recall initiation date
- Jan 8, 2019
- Initial firm notification
- Press Release
- Center classification date
- Jan 22, 2019