Why it was recalled
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
Product description
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
Lot numbers, UPCs & expiration codes
Lot: 1220062085 Exp. 03/2020
Where it was sold
Nationwide within the USA.
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-0246-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 15, 2018
- FDA report date
- Nov 21, 2018
- Quantity
- 16 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zero Xtreme USA
Original FDA data
Every field from FDA enforcement report D-0246-2019, exactly as published.
Show all FDA fields
- City
- Aventura
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 81436
- Address
- 20533 Biscayne Blvd # 825
- Code information
- Lot: 1220062085 Exp. 03/2020
- Postal code
- 33180-1529
- Report date
- Nov 21, 2018
- Product type
- Drugs
- Recall number
- D-0246-2019
- Classification
- Class II
- Recalling firm
- Zero Xtreme USA
- Product quantity
- 16 bottles
- Termination date
- Jan 18, 2022
- Reason for recall
- Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
- Distribution pattern
- Nationwide within the USA.
- Recall initiation date
- Oct 15, 2018
- Initial firm notification
- Press Release
- Center classification date
- Nov 15, 2018