Status
Terminated
Drug Enforcement D-370-2014
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.
Classification
Class I
Report Date
December 25, 2013
Termination Date
November 21, 2014
Product Information
- 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
- Product quantity
- 16126 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Canada to distributors and consumers.
Location & Firm
- Recalling firm
- Zi Xiu Tang Success, LLC
- Address
-
177 Creek Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-370-2014
- Event ID
- 63525
- Recall initiation date
- October 22, 2012
- Center classification date
- December 18, 2013
- Code info
- Lot numbers: 05/25/2012, Exp 05/24/14; 07/29/2012, Exp 07/28/14; and 08/05/2012, Exp 08/04/14
- More code info
- —