FDA recall D-370-2014

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.

Distribution

Nationwide and Canada to distributors and consumers.

Key facts

Status

Terminated

Initiation date

2012-10-22

Report date

2013-12-25

Termination date

2014-11-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kutztown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-370-2014