Why it was recalled
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Product description
Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1
Lot numbers, UPCs & expiration codes
Lot numbers: 05/25/2012, Exp 05/24/14; 07/29/2012, Exp 07/28/14; and 08/05/2012, Exp 08/04/14
Where it was sold
Nationwide and Canada to distributors and consumers.
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-370-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 22, 2012
- FDA report date
- Dec 25, 2013
- Quantity
- 16126 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zi Xiu Tang Success, LLC
Original FDA data
Every field from FDA enforcement report D-370-2014, exactly as published.
Show all FDA fields
- City
- Kutztown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 63525
- Address
- 177 Creek Rd
- Code information
- Lot numbers: 05/25/2012, Exp 05/24/14; 07/29/2012, Exp 07/28/14; and 08/05/2012, Exp 08/04/14
- Postal code
- 19530-9043
- Report date
- Dec 25, 2013
- Product type
- Drugs
- Recall number
- D-370-2014
- Classification
- Class I
- Recalling firm
- Zi Xiu Tang Success, LLC
- Product quantity
- 16126 bottles
- Termination date
- Nov 21, 2014
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1
- Distribution pattern
- Nationwide and Canada to distributors and consumers.
- Recall initiation date
- Oct 22, 2012
- Initial firm notification
- Letter
- Center classification date
- Dec 18, 2013