martes, 27 de febrero de 2018

FDA MedWatch - Bella Diet Capsules by Bella All Natural: Recall - Presence of Sibutramine

U.S. Food and Drug Administration Header

Bella Diet Capsules by Bella All Natural: Recall - Presence of Sibutramine

AUDIENCE: Consumer
ISSUE: Bella All Natural is voluntarily recalling its Diet Capsules labeled as Bella, Lot Number MFD:10.15.2017 EXP: 10.14.2019, to the consumer level.
This recall has been initiated due to presence of sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to safety concerns. N-Desmethyl sibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present significant health risks including heart attack, arrhythmia, and stroke.
BACKGROUND: The product is used as a diet pill and is packaged in a plastic bottle, with 30 pills, and with the Lot Number MFD:10.15.2017 EXP: 10.14.2019. Bella was distributed in California via internet and retail.
RECOMMENDATION: Bella All Natural is notifying its distributors and customers by Customer Notification/Recall Communication and is arranging for return of product of all recalled products. Consumers that have Bella Diet Capsules which is being recalled should stop using immediately and return to place of purchase.
Consumers with questions regarding this recall can contact Bella all Natural by calling (323) 552-6263, or e-mail address: cabral_daisy@yahoo.com on Monday-Sunday, 10 a.m. - 5:30 p.m., PST. 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.
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.fda.gov/MedWatch/report
  • 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
Read the MedWatch Safety Alert, including a link to the Press Release, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm598464.htm

4 comentarios:

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