FDA Recall D-0977-2015
Detox Transforms · Garner, NC
Class I — life-threatening Terminated 729 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00417 4.
Reason for recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.
Recall record
- Recall number
D-0977-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- WV who distributed Nationwide.
- Recall initiated
- 2015-01-25
- Classified by FDA Center
- 2015-05-04
- FDA published
- 2015-05-13
- Terminated
- 2017-01-23
- Recalling firm
- Detox Transforms
- Firm location
- Garner, NC