FDA Recall D-370-2014
Zi Xiu Tang Success, LLC · Kutztown, PA
Class I — life-threatening Terminated 760 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1
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 record
- Recall number
D-370-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide and Canada to distributors and consumers.
- Recall initiated
- 2012-10-22
- Classified by FDA Center
- 2013-12-18
- FDA published
- 2013-12-25
- Terminated
- 2014-11-21
- Recalling firm
- Zi Xiu Tang Success, LLC
- Firm location
- Kutztown, PA