Townsend Farms, Inc. of Fairview, Oregon, out of an abundance of caution and in cooperation with the FDA is expanding its voluntary recall efforts and is now recalling Townsend Farms Organic Antioxidant Blend, 3 lb. bag with UPC 0 78414 40444 8. The recall codes are located on the back of the package with the words “BEST BY” followed by the code T122114 sequentially through T053115, followed by a letter.
Harmony Chai Voluntary Recall of Concentrated Black Spiced Chai and Decaffeinated Rooibos Chai
Harmony Chai of Eastsound, WA is voluntarily recalling its Concentrated Black Spiced Chai and Decaffeinated Rooibos Chai because it may not be properly processed. Although Harmony Chai has received no complaints of illness related to the consumption of the recalled product, there is a potential hazard that can occur when tea beverages are inadequately processed.
FDA approves the first non-hormonal treatment for hot flashes associated with menopause
The U.S. Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.
Federal judge enters consent decree with Med Prep Consulting
A federal judge from the U.S. District Court for New Jersey has entered a consent decree of permanent injunction against Med Prep Consulting, Inc., a pharmacy licensed by the state of New Jersey, and Gerald R. Tighe, the company’s president and owner. The U.S. Department of Justice sought the consent decree on behalf of the U.S. Food and Drug Administration.
Medtronic Issues Medical Device Notifications Regarding The Synchromed Implantable Infusion System
June 26, 2013 – MINNEAPOLIS – In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.
Dolphin Intertrade Corp
Miami, Florida Dolphin Intertrade Corp. is voluntary recalling “JaDera” and “Xiyouji Qingzhi” Weight Loss Supplement. These product have been found to contain undeclared Sibutramine, Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
Read The Complete Story!
FDA approves first recombinant coagulation factor IX that is specifically indicated for routine use in preventing bleeding episodes (prophylaxis)
The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes, perioperative (period extending from the time of hospitalization for surgery to the time of discharge) management, and routine use to prevent or reduce the frequency of bleeding episodes (prophylaxis).
FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, and seizure of offending websites and $41,104,386 worth of illegal medicines worldwide.
Respironics California, Inc. Recall of V60 Ventilator Designated Class I by FDA
Respironics California, Inc., a Philips Healthcare business, today announced that the company’s worldwide recall of approximately 19,200 Philips Respironics V60 Ventilators has been designated a Class I recall by the U.S. Food and Drug Administration (FDA). On June 4, Respironics initiated a voluntary recall to correct a software issue that may cause the V60 ventilator device to shut down.
Scenic Fruit Company Recalls Woodstock Frozen Organic Pomegranate Kernels Due To Possible Health Risk
Scenic Fruit Company of Gresham, Oregon today announced it is voluntarily recalling 5,091 cases (61,092 eight ounce bags) of Woodstock Frozen Organic Pomegranate Kernels. Based on an ongoing epidemiological and traceback investigation by the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) of an illness outbreak, the kernels have the potential to be contaminated with Hepatitis A virus.