D-0223-2017 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 28, 2016
- Initiation Date
- October 28, 2016
- Termination Date
- April 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 bottles
Product Description
Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
Reason for Recall
Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
Distribution Pattern
Nationwide
Code Information
Bottles stamped MFD: 03.07.2016 EXP: 03.06.2018