Why it was recalled
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein
Product description
ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068.
Lot numbers, UPCs & expiration codes
All lots/codes/bottles/packages.
Where it was sold
Nationwide and Puerto Rico Foreign: Spain and Ecuador
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-0991-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 10, 2015
- FDA report date
- May 13, 2015
- Quantity
- 636 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ultra ZX Supplements
Original FDA data
Every field from FDA enforcement report D-0991-2015, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 70661
- Address
- 2525 SW 3rd Ave Apt 1704
- Code information
- All lots/codes/bottles/packages.
- Postal code
- 33129-2068
- Report date
- May 13, 2015
- Product type
- Drugs
- Recall number
- D-0991-2015
- Classification
- Class I
- Recalling firm
- Ultra ZX Supplements
- Product quantity
- 636 bottles
- Termination date
- Apr 26, 2018
- Reason for recall
- Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068.
- Distribution pattern
- Nationwide and Puerto Rico Foreign: Spain and Ecuador
- Recall initiation date
- Mar 10, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 5, 2015