D-1165-2016 Class I Ongoing
FDA drug recall D-1165-2016 was initiated by XTREME Z DISTRIBUTORS INC on July 2, 2015 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine. The recall status is ongoing. Affected quantity: 70,350 capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- July 13, 2016
- Initiation Date
- July 2, 2015
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70,350 capsules
Product Description
Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180
Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
Distribution Pattern
Nationwide
Code Information
Lot 1220062085, Exp. 09/16