Adipotrim XT by Deseo Rebajar: Recall - Undeclared Drug Ingredient
Audience: Consumer, Health Professional
ISSUE: Deseo Rebajar Inc., is voluntarily recalling lot #052012 of Adipotrim XT sold directly to individual customers in Fajardo, Caguas and Bayamon. The FDA laboratory analysis found it to contain undeclared Fluoxetine. Fluoxetine 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 dysphoric disorder (PMDD), making Adipotrim XT an unapproved drug.
Use 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.
BACKGROUND: 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.
RECOMMENDATION: Consumers, distributors and retailers that have the product being recalled should stop using and return the product immediately to the place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Deseo Rebajar Inc. is notifying their distributors and customers by phone. Consumers with questions should contact Deseo Rebajar Inc. at 787.961.6464 Monday - Friday, 8:00 am - 5:00 pm, [GMT time zone].
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[11/14/2013 - Press Release - Deseo Rebajar Inc]
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