Drug product
Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA ---- UPC Code 680474015795
D-0964-2017
Product summary
- Event
- Event 77055
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0964-2017
Official wording
Reason: Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
Code information: All lots and package sizes
Distribution pattern: Nationwide via internet
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin