Why it was recalled
Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.
Product description
Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
Lot numbers, UPCs & expiration codes
Lot #: 052012, Exp 10/2015
Where it was sold
Nationwide and Puerto Rico
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-1277-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 7, 2013
- FDA report date
- May 7, 2014
- Quantity
- 1,146 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Deseo Rebajar
Original FDA data
Every field from FDA enforcement report D-1277-2014, exactly as published.
Show all FDA fields
- City
- Fajardo
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 66817
- Address
- G12 Calle Principal
- Address (line 2)
- Baralt Ste #3
- Code information
- Lot #: 052012, Exp 10/2015
- Postal code
- 00738-3774
- Report date
- May 7, 2014
- Product type
- Drugs
- Recall number
- D-1277-2014
- Classification
- Class I
- Recalling firm
- Deseo Rebajar
- Product quantity
- 1,146 bottles
- Termination date
- May 3, 2017
- Reason for recall
- Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Nov 7, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 25, 2014