Why it was recalled
Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
Product description
Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180
Lot numbers, UPCs & expiration codes
Lot 1220062085, Exp. 09/16
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-1165-2016
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Jul 2, 2015
- FDA report date
- Jul 13, 2016
- Quantity
- 70,350 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- XTREME Z DISTRIBUTORS INC
Original FDA data
Every field from FDA enforcement report D-1165-2016, exactly as published.
Show all FDA fields
- City
- Aventura
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 72227
- Address
- 3300 NE 191st St Apt 813
- Code information
- Lot 1220062085, Exp. 09/16
- Postal code
- 33180-2444
- Report date
- Jul 13, 2016
- Product type
- Drugs
- Recall number
- D-1165-2016
- Classification
- Class I
- Recalling firm
- XTREME Z DISTRIBUTORS INC
- Product quantity
- 70,350 capsules
- Reason for recall
- Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 2, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 6, 2016