D-1148-2016 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 13, 2016
- Initiation Date
- December 15, 2015
- Termination Date
- April 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu Tang Success, LLC Trexlertown, PA 18087, USA www.zixiutangsuccess.com
Reason for Recall
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
Distribution Pattern
Nationwide
Code Information
All lots