D-1373-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 18, 2014
- Initiation Date
- January 24, 2014
- Termination Date
- October 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 boxes
Product Description
Fruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
Reason for Recall
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .
Distribution Pattern
Nationwide
Code Information
ALL LOTS