Food Recalls (FDA)
Deseo Rebajar Inc. Issues Voluntary Puerto Rico Recall of Adipotrim XT Due to Underclared FluoxetinePublished on Thursday, 21 November 2013 17:42
- Category: Food Recalls (FDA)
Recall -- Firm Press Release
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Deseo Rebajar Inc. Issues Voluntary Puerto Rico Recall of Adipotrim XT Due to Underclared Fluoxetine
FOR IMMEDIATE RELEASE — November 14, 2013 – (Worldwide) Deseo Rebajar Inc., is voluntarily recalling lot #052012 of Adipotrim XT to the consumer level. 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. No illnesses or injuries have been reported to Deseo Rebajar Inc. to date in connection with the use of this product.
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 in website www.deseorebajar.com. We sincerely regret any inconvenience to our customers.
Deseo Rebajar Inc. is notifying their distributors and customers by phone. Consumers/Distributors/Retailers that have the product being recalled should stop using and return the product immediately to the place of purchase.
Consumers with questions should contact Deseo Rebajar Inc. at 787.961.6464 or via e-mail at firstname.lastname@example.org Monday - Friday, 8:00 am - 5:00 pm, [GMT time zone]. 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.
Adverse events that may be related to the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
- This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
- Deseo Rebajar Inc. is taking this voluntary action because it is committed to the health and safety of its customers and to the quality of its select brands. We are working diligently to make available appropriate natural herbal regulations. We are moving forward with new custom formula. We value our relationship with you and will continue to provide you with the best possible service. Thank you for your continued business and allowing us to be a trusted partner.
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.
Read More » http://www.fda.gov/Safety/Recalls/ucm376157.htm