D-0654-2020 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 22, 2020
- Initiation Date
- December 17, 2019
- Termination Date
- October 29, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 boxes
Product Description
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
Distribution Pattern
TX
Code Information
All lots remaining within expiry.