Drug product
Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0
D-1085-2019
Product summary
- Event
- Event 82419
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1085-2019
Official wording
Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
Code information: All lots
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.