D-0657-2020 Class I Terminated
FDA drug recall D-0657-2020 was initiated by Motto International Corp on December 17, 2019 and is designated Class I. Reason for recall: Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil The recall status is terminated (terminated October 29, 2021). Affected quantity: 1 box.
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
- 1 box
Product Description
Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, 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.