All Fruta Planta products being recalled by maker because it contains sibutramine
Kissimmee, FL – PRock Marketing LLC is recalling all lots of Fruta Planta and Reduce Weight Fruta Planta. This is a single product marketed under two brand names. (See Fruta Planta label)
FDA testing confirmed that Fruta Planta contains sibutramine, a drug withdrawn from the market in December 2010 for safety reasons.
The FDA has received multiple reports of adverse events associated with the use of Fruta Planta and Reduce Weight Fruta Planta, including several cardiac events and one death.
Consumers should stop using this product immediately and throw it away in a sealed container where children and animals cannot gain access to it. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
What is the Problem?
PRock Marketing LLC, is voluntarily recalling all lots of Fruta Planta and Reduce Weight Fruta Planta because FDA testing determined that the product contains sibutramine. Sibutramine is a drug that was withdrawn from the market in December 2010 for safety reasons. The FDA has received multiple reports of adverse events associated with the use of Fruta Planta and Reduce Weight Fruta Planta, including several cardiac events and one death.
What are the Symptoms of Illness/Injury?
Fruta Planta and Reduce Weight Fruta Planta poses a threat to consumers because sibutramine is known to increase blood pressure and/or pulse rate in some patients and may present a serious risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Sibutramine may also interact in life-threatening ways with other medications a consumer may be taking.
What Do Consumers Need To Do?
Consumers should stop using this product immediately. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. PRock Marketing’s recall notice recommends that consumers throw the product away in a sealed container where children and animals cannot gain access to it or return it to the company. Consumers may reach the company at 877-225-1009 Monday through Friday from 10:00am to 4:30pm.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by:
- Completing and submitting the adverse report Online: www.fda.gov/MedWatch/report.htm;
- Downloading the pre-addressed, postage-paid FDA Form 3500 (or calling 1-800-332-1088 to request the form), completing it and faxing it to 1-800-FDA-0178;
- or Mailing the completed form to MedWatch 5600 Fishers Lane, Rockville, MD 20857.
What Does the Product Look Like?
Fruta Planta and Reduce Weight Fruta Planta is available in 30-capsule boxes. (See Fruta Planta label)
Where is it Distributed?
Fruta Planta and Reduce Weight Fruta Planta is sold online at www.frutaplanta.com and other online retailers.
Who Should be Contacted?
PRock Marketing’s recall notice recommends that consumers destroy the product or return it to the company. Consumers may reach the company at 877-225-1009 Monday through Friday from 10:00am to 4:30pm.
For more information:
FDA Public Notification: Fruta Planta Contains Undeclared Drug Ingredient
FDA Medication Health Fraud Page: Fraud Page
Sign up for RSS feed on Tainted Products Marketed as Dietary Supplements: RSS Feed
The information in this press release reflects FDA’s best efforts to communicate what the manufacturer has reported to FDA.
