Why it was recalled
Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
Product description
LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide via Internet sales
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-0860-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 3, 2015
- FDA report date
- Jun 1, 2016
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lipo Escultura Corp.
Original FDA data
Every field from FDA enforcement report D-0860-2016, exactly as published.
Show all FDA fields
- City
- Brooklyn
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 72782
- Address
- 888 Wyckoff Ave
- Code information
- All lots
- Postal code
- 11237-6116
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0860-2016
- Classification
- Class I
- Recalling firm
- Lipo Escultura Corp.
- Product quantity
- unknown
- Termination date
- Apr 17, 2017
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com
- Distribution pattern
- Nationwide via Internet sales
- Recall initiation date
- Dec 3, 2015
- Initial firm notification
- Press Release
- Center classification date
- May 23, 2016