FDA recall D-0633-2020

Natures Rx · Class I · drug

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.

Distribution

Nationwide in the U.S.

Key facts

Status
Terminated
Initiation date
2019-11-13
Report date
2020-01-08
Termination date
2023-02-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Claremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0633-2020