Why it was recalled
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement
Product description
Burn 7 Capsules, supplied in 30 capsules bottle
Lot numbers, UPCs & expiration codes
MFD: 07.18.2013, EXP: 07.17.2015
Where it was sold
Puerto Rico only
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-1351-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 23, 2013
- FDA report date
- Jun 4, 2014
- Quantity
- 120 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Deseo Rebajar
Original FDA data
Every field from FDA enforcement report D-1351-2014, exactly as published.
Show all FDA fields
- City
- Fajardo
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 67162
- Address
- G12 Calle Principal
- Address (line 2)
- Baralt Ste #3
- Code information
- MFD: 07.18.2013, EXP: 07.17.2015
- Postal code
- 00738-3774
- Report date
- Jun 4, 2014
- Product type
- Drugs
- Recall number
- D-1351-2014
- Classification
- Class I
- Recalling firm
- Deseo Rebajar
- Product quantity
- 120 bottles
- Termination date
- May 3, 2017
- Reason for recall
- Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Burn 7 Capsules, supplied in 30 capsules bottle
- Distribution pattern
- Puerto Rico only
- Recall initiation date
- Dec 23, 2013
- Initial firm notification
- Press Release
- Center classification date
- May 27, 2014