FDA Recall D-0388-2019
Happy Together, Inc. · Boynton Beach, FL
Class I — life-threatening Terminated 1022 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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
Recall record
- Recall number
D-0388-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Product was sold over the internet
- Recall initiated
- 2019-01-08
- Classified by FDA Center
- 2019-01-22
- FDA published
- 2019-01-30
- Terminated
- 2021-10-26
- Recalling firm
- Happy Together, Inc.
- Firm location
- Boynton Beach, FL