D-1594-2014 Class I Terminated
FDA drug recall D-1594-2014 was initiated by Nature's Universe on April 9, 2014 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. The recall status is terminated (terminated April 10, 2015). Affected quantity: Unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- September 24, 2014
- Initiation Date
- April 9, 2014
- Termination Date
- April 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Count Bottles, THINOGENICS LLC, Nashville, TN 37203 USA.
Reason for Recall
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Distribution Pattern
U.S. Nationwide and Canada
Code Information
None Available. All lots distributed prior to 02/06/2014 are being recalled.