D-0994-2015 Class I Terminated
FDA drug recall D-0994-2015 was initiated by REFA Enterprises, LLC on November 3, 2014 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein The recall status is terminated (terminated November 4, 2015). Affected quantity: 92 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 13, 2015
- Initiation Date
- November 3, 2014
- Termination Date
- November 4, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 92 bottles
Product Description
Forever Beautiful BEE POLLEN, capsules, 250mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA
Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Distribution Pattern
Nationwide
Code Information
UPC CODE: 633090804632, Exp unknown