D-0500-2019 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 13, 2019
- Initiation Date
- January 25, 2019
- Termination Date
- February 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 211
Product Description
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
Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Distribution Pattern
eBay sales
Code Information
All lots within expiry