FDA Recall D-0633-2020
Natures Rx · Claremont, CA
Class I — life-threatening Terminated 1183 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698.
Reason for recall
Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Recall record
- Recall number
D-0633-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the U.S.
- Recall initiated
- 2019-11-13
- Classified by FDA Center
- 2019-12-31
- FDA published
- 2020-01-08
- Terminated
- 2023-02-08
- Recalling firm
- Natures Rx
- Firm location
- Claremont, CA