D-0388-2019 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 30, 2019
- Initiation Date
- January 8, 2019
- Termination Date
- October 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Distribution Pattern
Product was sold over the internet
Code Information
All lots within expiry