EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.
What was recalled
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.
- Recalling firm
- Detox Transforms
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0977-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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