Why it was recalled
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Product description
Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide
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-0877-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 3, 2015
- FDA report date
- Jun 1, 2016
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Centro Naturista
Original FDA data
Every field from FDA enforcement report D-0877-2016, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 71401
- Address
- 14211 Coit Rd
- Address (line 2)
- Ste H
- Code information
- All lots
- Postal code
- 75254-2862
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0877-2016
- Classification
- Class I
- Recalling firm
- Centro Naturista
- Product quantity
- Unknown
- Termination date
- Mar 30, 2017
- Reason for recall
- Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 3, 2015
- Initial firm notification
- Press Release
- Center classification date
- May 26, 2016