D-1375-2014 Class I Terminated
FDA drug recall D-1375-2014 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 ingredient: Phenolphthalein The recall status is terminated (terminated October 2, 2019). Affected quantity: unknown.
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
- unknown
Product Description
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
Distribution Pattern
Nationwide
Code Information
ALL LOTS