FDA Recall D-0654-2020
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
Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 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-0654-2020- 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