D-1249-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2014
- Initiation Date
- May 20, 2013
- Termination Date
- June 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 998 boxes
Product Description
JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle
Reason for Recall
Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Distribution Pattern
Nationwide
Code Information
Manufacturing Codes: 10.06.2011 Exp. 09.06.2013