FDA Recall D-0500-2019
Natures Rx · Claremont, CA
Class I — life-threatening Terminated 1473 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
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-0500-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- eBay sales
- Recall initiated
- 2019-01-25
- Classified by FDA Center
- 2019-02-15
- FDA published
- 2019-02-13
- Terminated
- 2023-02-06
- Recalling firm
- Natures Rx
- Firm location
- Claremont, CA