FDA Recall D-0655-2020
Motto International Corp · Dallas, TX
Class I — life-threatening Terminated 682 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX
Reason for recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Recall record
- Recall number
D-0655-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- TX
- Recall initiated
- 2019-12-17
- Classified by FDA Center
- 2020-01-10
- FDA published
- 2020-01-22
- Terminated
- 2021-10-29
- Recalling firm
- Motto International Corp
- Firm location
- Dallas, TX