Status
Terminated
Drug Enforcement D-369-2014
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
- Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 6 937000 700019
- Product quantity
- 6084 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-369-2014
- Event ID
- 63525
- Recall initiation date
- October 22, 2012
- Center classification date
- December 18, 2013
- Code info
- Lot numbers: 04/15/2012, Exp 04/15/14; 05/15/2012, Exp 05/15/14; 06/15/2012, Exp 06/15/14; and 07/15/2012, Exp 07/15/14
- More code info
- —