En Español Get Consumer Updates by email. Last year in the United States, more than 136,000 people were diagnosed with—and more than 50,000 died from—colorectal cancer, according to the National Cancer Institute. It is the second leading cause of cancer-related deaths in the United States, striking some groups more often…
March 13, 2017: Vice-President of SK Labs Found Guilty of Conspiracy, Mail Fraud Charges
Food and Drug Administration Office of Criminal Investigations Sitesh Bansi Patel Found Guilty Following Five-Day Jury Trial Abingdon, VIRGINIA – An Irvine, California, man was found guilty Friday afternoon following a five-day jury trial on conspiracy and mail fraud charges in relation to his role in…
FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder
The U.S. Food and Drug Administration (FDA) is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or…
Viberzi (eluxadoline): Drug Safety Communication – Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder
[Posted 03/15/2017] AUDIENCE: Gatroenterology, Patient ISSUE: FDA is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that…
Public Notification: Bl4ck 4K Capsules Contain Hidden Drug Ingredient
[12-22-2016] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Bl4ck 4K Capsules, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments. FDA laboratory analysis confirmed that Bl4ck 4K capsules contain sildenafil, the active ingredient…
Dolcetta Artisan Sweets Issues Allergy Alert on Undeclared Soy and Milk in Chocolate Confections
Dolcetta Artisan Sweets of Seattle, WA is recalling Dolcetta branded chocolate confections because they may contain undeclared soy and milk. Article source: http://www.fda.gov/Safety/Recalls/ucm546757.htm
SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall – Failure of Priming Bolus
[Posted 03/14/2017] AUDIENCE: Risk Manager, Patient ISSUE: Medtronic is recalling the SynchroMed Implantable Infusion Pumps because a software problem may cause unintended delivery of drugs during a priming bolus procedure, used to quickly deliver large dose of medication from the device to the patient’s spine. During this procedure, patients may…
Whole Foods Market Expands Vulto Creamery Recall Because of Public Health Risk
In response to Vulto Creamery’s expanded recall of raw milk cheeses, Whole Foods Market is voluntarily expanding its recall to include Andes, Hamden and Walton Umber cheeses sold in eight stores in Massachusetts, New Jersey and New York. The cheeses have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which…
Public Notification: Duramaxxx Contains Hidden Drug Ingredient
[12-22-2016] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Duramaxxx, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments. FDA laboratory analysis confirmed that Duramaxxx contains sildenafil, the active ingredient in the FDA-approved prescription…
Public Notification: Queen Slimming Soft Gel Contains Hidden Drug Ingredient
[12-22-2016] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Queen Slimming Soft Gel, a product promoted for weight loss. This product was identified by FDA during an examination of international mail shipments. FDA laboratory analysis confirmed that Queen Slimming Soft Gel contains sibutramine. Sibutramine is a controlled substance that…