D-0222-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 28, 2016
- Initiation Date
- April 29, 2016
- Termination Date
- September 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1000 bottles
Product Description
3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Reason for Recall
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Distribution Pattern
Nationwide
Code Information
All lots