Deseo Rebajar Inc., is voluntarily recalling Adipotrim XT, a dietary supplement sold directly to customers in Fajardo, Caguas and Bayamon, Puerto Rico, and online. A U.S. Food and Drug Administration (FDA) laboratory analysis found it to contain undeclared fluoxetine, a selective serotonin reuptake inhibitor (SSRI) drug.
Fluoxetine, the active ingredient in Prozac, is FDA-approved for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphoric disorder (PMDD). Adipotrim XT is marketed as a natural herbal dietary supplement to aid weight loss, but the presence of fluoxetine makes Adipotrim XT an unapproved drug, the FDA explained in the recall notice.
SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. When a patient is taking 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.
The recalled products are packaged in 30-count bottles with lot number #052012.
Consumers should stop using the product immediately and return it to the place of purchase. The FDA advises consumers to contact a physician if they have experienced any problems that may be related to taking or using this drug product. The FDA encourages health care professionals and patients to report adverse events or side effects related Adipotrim XT to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.htm
Consumers with questions about the recall may contact Deseo Rebajar Inc. at 787.961.6464 or via e-mail at firstname.lastname@example.org Monday through Friday, 8:00 am to 5:00 pm, [GMT time zone].