Recalls / Class I
Class ID-1375-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- ALL LOTS
Why it was recalled
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein
Recalling firm
- Firm
- MyNicNaxs, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1012 Alpine Dr, N/A, Deltona, Florida 32725-7204
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-01-24
- FDA classified
- 2014-06-12
- Posted by FDA
- 2014-06-18
- Terminated
- 2019-10-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1375-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.