FDA Recall D-0470-2018
www.blankterrmall.com · Olean, NY
Class I — life-threatening Terminated 387 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-0470-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Product was distributed in the United States.
- Recall initiated
- 2017-11-19
- Classified by FDA Center
- 2018-02-20
- FDA published
- 2018-01-31
- Terminated
- 2018-12-11
- Recalling firm
- www.blankterrmall.com
- Firm location
- Olean, NY