Why it was recalled
Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.
Product description
Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida
Lot numbers, UPCs & expiration codes
Lot # 000815004400; Exp 12/17
Where it was sold
Nationwide and Colombia, South America
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0664-2016
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jul 13, 2015
- FDA report date
- Feb 24, 2016
- Quantity
- 783 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Life and More LLC
Original FDA data
Every field from FDA enforcement report D-0664-2016, exactly as published.
Show all FDA fields
- City
- Doral
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 71733
- Address
- 5771 NW 112th Ave Apt 112
- Code information
- Lot # 000815004400; Exp 12/17
- Postal code
- 33178-4161
- Report date
- Feb 24, 2016
- Product type
- Drugs
- Recall number
- D-0664-2016
- Classification
- Class I
- Recalling firm
- Life and More LLC
- Product quantity
- 783 bottles
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida
- Distribution pattern
- Nationwide and Colombia, South America
- Recall initiation date
- Jul 13, 2015
- Initial firm notification
- Center classification date
- Feb 12, 2016