FDA warns vs unregistered slimming coffee; batch of slimming capsules recalled

MANILA, Philippines — The Food and Drug Administration (FDA) has warned the public against an unregistered slimming coffee being sold in the market and a drug used for weight management and treatment of obesity found without the pharmaceutical active ingredient.
In an advisory, the regulatory body ordered the seizure of Bavarian Brew Slimming Coffee from the market for failing to undergo the necessary government evaluation and registration to certify its safety and efficacy.

“All establishments and outlets are hereby warned against selling and/or dispensing the identified product. Anyone found selling the said product will be penalized,” warned the FDA.

It has also urged all local government units and law enforcement agencies to make sure that the unregistered coffee product are not sold or offered for sale in their respective areas of jurisdiction.

The FDA reminded consumers that health products should undergo evaluation, registration and testing by the government to ensure their quality, safety and efficacy and that medications be purchased from FDA-licensed establishments.

In a separate advisory, it announced that a batch of Orlistat (Reducin) 120 mg capsule manufactured in China was being recalled from the market for the absence of the active pharmaceutical ingredient, orlistat.

The recall order was directed at Batch Number RD-TTI of Reducin with an expiry date of August 2016. The importer of the drug has been identified as Golden Dale Pharma Corp. based in Quezon City.

“The affected product batch present safety risks and potential adverse health consequences. Therefore, distributors, retailers, hospitals, pharmacies or clinics that have the affected batch are instructed to discontinue further distribution, sale and use,” said the regulatory body.

The recall was prompted after results of the test conducted on the specific batch by the FDA’s central laboratory showed negative for the presence of orlistat, a drug designed to promote weight loss, it said.

The FDA ordered all its regulation officers to monitor the presence of the affected product batch in the market and to seal discovered stocks. FDA officers have also been instructed to order concerned establishments to return the sealed stocks to the market authorization holder for proper destruction.

“Any suspected adverse reaction experienced from the use of the aforementioned product batch should be reported immediately to FDA by visiting www.fda.gov.ph/adr-report-new and fill out all of the required fields,” the FDA urged consumers.  SFM