D-0470-2018 Class I Terminated
FDA drug recall D-0470-2018 was initiated by www.blankterrmall.com on November 19, 2017 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil. The recall status is terminated (terminated December 11, 2018). Affected quantity: 10 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- January 31, 2018
- Initiation Date
- November 19, 2017
- Termination Date
- December 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 boxes
Product Description
Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA
Reason for Recall
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
Distribution Pattern
Product was distributed in the United States.
Code Information
All lots within expiry.