November 22, 2013
Deseo Rebajar Inc. Recalls Adipotrim XT Due to Undeclared Fluoxetine
The Missouri Department of Health and Senior Services received information regarding a recall of lot #052012 of Adipotrim XT. The FDA laboratory analysis of this dietary supplement found to contain undeclared Fluoxetine. Flouxetine is an FDA approved drug in a class of drugs called selective serotonin reuptake inhibitors (SSRIs) used for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder and premenstrual dysphonic disorder (PMDD), making Adipotrim XT an unapproved drug.
Uses of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding and seizures. In patients on other medications for common conditions (aspirin, ibuprofen or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions and psychosis), ventricular arrhythmia or sudden death can occur.
Adipotrim XT is marketed as a natural herb dietary supplement for weight loss. The recalled products are packaged in 30-count plastic bottles labeled with lot number #052012. The product lot was sold directly to individual customers in our offices in Fajardo, Caguas and Bayamon and online.
The full recall can be found at www.fda.gov/Safety/Recalls/ucm376157.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.