D-0246-2019 Class II Terminated
FDA drug recall D-0246-2019 was initiated by Zero Xtreme USA on October 15, 2018 and is designated Class II. Reason for recall: Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine The recall status is terminated (terminated January 18, 2022). Affected quantity: 16 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 21, 2018
- Initiation Date
- October 15, 2018
- Termination Date
- January 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 bottles
Product Description
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
Reason for Recall
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
Distribution Pattern
Nationwide within the USA.
Code Information
Lot: 1220062085 Exp. 03/2020