Drug product
the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, Piperine), 10 count mylar package, Nature's Rx, Claremont, CA
D-0500-2019
Product summary
- Firm
- Natures Rx
- Event
- Event 81999
- Status
- Terminated
- Classification
- Class I
- Quantity
- 211
- Official record key
drug-enforcement:D-0500-2019
Official wording
Reason: Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Code information: All lots within expiry
Distribution pattern: eBay sales
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil