D-0675-2016 Class I Terminated
FDA drug recall D-0675-2016 was initiated by Inaffit, LLC on October 5, 2015 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. The recall status is terminated (terminated March 14, 2016). Affected quantity: 6000 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 24, 2016
- Initiation Date
- October 5, 2015
- Termination Date
- March 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6000 Bottles
Product Description
NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.
Reason for Recall
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Distribution Pattern
Nationwide
Code Information
All lots