D-1373-2014 Class I Terminated

Recalled by MyNicNaxs, Inc. — Deltona, FL

FDA drug recall D-1373-2014 was initiated by MyNicNaxs, Inc. on January 24, 2014 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein . The recall status is terminated (terminated October 2, 2019). Affected quantity: 2 boxes.

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