D-0633-2020 Class I Terminated
FDA drug recall D-0633-2020 was initiated by Natures Rx on November 13, 2019 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil. The recall status is terminated (terminated February 8, 2023). Affected quantity: 2,800 capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- January 8, 2020
- Initiation Date
- November 13, 2019
- Termination Date
- February 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,800 capsules
Product Description
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 Pattern
Nationwide in the U.S.
Code Information
Lot # 01251ZX1, exp. date 11/2022 UPC: 610877392698