Grand Prairie, TX, Dream Body Weight Loss is voluntarily recalling all lots of Dream Body Extreme Gold 800mg 30 gold capsules, Dream Body 450mg 30 white capsules, and Dream Body Advanced 400mg 30 purple capsules to the consumer level. The Dream Body Extreme 800mg Gold, Dream Body 450mg and Dream Body Advanced 400mg have been found to contain sibutramine after FDA sampling and testing.
General Mills Expands Flour Recall to Include Additional Dates from Last Fall
General Mills of Minneapolis, MN, continues to collaborate with health officials to investigate a multistate outbreak of E. coli O121, and is expanding its recall of Gold Medal flour, Wondra flour, and Signature Kitchens flour to include flour made earlier in the fall that may still be in consumers’ pantries. The recall is being expanded due to a newly-reported illness that appears to have stemmed from the consumption of raw dough or batter linked to flour produced last fall.
Eastland Food Corp. Issues Allergy Alert on Undeclared Milk in Euro Custard Cakes
Eastland Food Corp. (Columbia, Maryland) is announcing a limited voluntary recall of a single lot of Euro Custard Cake because it contains an undeclared milk ingredient. People who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume the affected Euro Custard Cake.
FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens
The U.S. Food and Drug Administration today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as Carbapenem-resistant Enterobacteriaceae, or CRE, and have been reported in almost all states within the U.S.
FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens
The U.S. Food and Drug Administration today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as Carbapenem-resistant Enterobacteriaceae, or CRE, and have been reported in almost all states within the U.S.
FDA approves implantable device that changes the shape of the cornea to correct near vision
The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision.
FDA approves implantable device that changes the shape of the cornea to correct near vision
The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision.
FDA requests additional information to address data gaps for consumer hand sanitizers
The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs (including hand sanitizers) marketed over-the-counter (OTC). The FDA’s request for more data is intended to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns, and does not mean the FDA believes these products are ineffective or unsafe.
Statement from FDA Commissioner Robert Califf, M.D. announcing the acting director of the FDA Oncology Center of Excellence
The FDA is honored to be an integral part of the Vice President’s National Cancer Moonshot Initiative (“Cancer Moonshot”), which calls on the agency to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices to create the Oncology Center of Excellence (OCE). The OCE will expedite the development of novel combination products and support an integrated approach to tackle this devastating disease that touches so many American families.
FDA approves Epclusa for treatment of chronic Hepatitis C virus infection
The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.