FDA Recall D-1375-2014
MyNicNaxs, Inc. · Deltona, FL
Class I — life-threatening Terminated 2077 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd) 400 mg, supplied in 40 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 ingredient: Phenolphthalein
Recall record
- Recall number
D-1375-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2014-01-24
- Classified by FDA Center
- 2014-06-12
- FDA published
- 2014-06-18
- Terminated
- 2019-10-02
- Recalling firm
- MyNicNaxs, Inc.
- Firm location
- Deltona, FL