Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales
The FDA provides update on Essure postmarket review study as company prepares to halt sales of the device on December 31. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 20, 2018 Category: American Health Source Type: news
FDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation
FDA alerted parents, caregivers and health care providers to the safety risks that jewelry used for relieving teething pain pose for children. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 20, 2018 Category: American Health Source Type: news
FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice
FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA ’s compliance and enforcement policy regarding stem cells. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 20, 2018 Category: American Health Source Type: news
Wegmans Issues Voluntary Recall of Fresh Cauliflower Rice, Veggie/Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower
Rochester, NY – Wegmans Food Markets, Inc. has issued a voluntary recall of fresh Cauliflower Rice, Veggie Cauliflower Rice Blend and Stir-Fry Mix with Cauliflower, sold in the produce department between 12/7/18 and 12/18/18, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7 ). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condi tion can lead ...
Source: Food and Drug Administration - December 19, 2018 Category: Food Science Source Type: news
Medtronic Announces Worldwide Voluntary Field Corrective Action; Company Issues Software Update for Puritan Bennett ™ 980 (Pb980) Ventilator Series
Medtronic (NYSE:MDT) is notifying customers worldwide of a voluntary field corrective action for its Puritan Bennett ™ 980 (PB980) ventilator series.
Medtronic initiated this field action on September 19, 2018. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 19, 2018 Category: Food Science Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety
FDA announces steps being taken on two medical device programs: finalizing guidance on the Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP). (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 18, 2018 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA ’ s 2017 report on declining sales/distribution of antimicrobial drugs for food animals, a reflection of improved antimicrobial stewardship
FDA ’ s 2017 report of sales/distribution data for antimicrobial drugs for food animals showed a continued decline in sales, a reflection of improved antimicrobial stewardship (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 18, 2018 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA ’s 2017 report on declining sales/distribution of antimicrobial drugs for food animals, a reflection of improved antimicrobial stewardship
FDA ’s 2017 report of sales/distribution data for antimicrobial drugs for food animals showed a continued decline in sales, a reflection of improved antimicrobial stewardship (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 18, 2018 Category: American Health Source Type: news
Adam Bros. Farming, Inc. Recalls Red and Green Leaf Lettuce and Cauliflower Because of Possible Health Risk
Adam Bros. Farming, Inc. of Santa Maria, California is recalling red leaf lettuce, green leaf lettuce and cauliflower harvested on November 27 through 30, 2018 out of an abundance of caution, because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 18, 2018 Category: Food Science Source Type: news
Atherstone Foods Inc Issues Allergy Alert on Undeclared Soy in “Greens and Grains Hummus and Quinoa Tabouleh Wrap”
ATHERSTONE FOODS INC of Richmond, CA is recalling 14.6 ounce (414g) Greens and Grains Hummus and Quinoa Tabouleh Wrap, because it may contain undeclared soy, people who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 18, 2018 Category: Food Science Source Type: news
Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard
Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 17, 2018 Category: Food Science Source Type: news
Michigan-based food manufacturer agrees to stop operations after repeated food safety violations
Saranac Brand Foods, Inc. specialized in a variety of 35 different ready-to-eat foods, including prepared salads, dips, and sauces. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 17, 2018 Category: American Health Source Type: news
Inspired Organics Issues Voluntary Recall of Organic Almond Butter Due to Potential Health Risk
Inspired Organics, LLC has issued a voluntary recall of Organic Almond Butter due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 17, 2018 Category: Food Science Source Type: news
Spokane Produce Voluntarily Recalls Northwest Cuisine Creations and Fresh & Local Sandwiches and Green Leaf Lettuce Filets
Spokane Produce Inc. of Spokane, WA initiates a voluntary recall of sandwiches containing green leaf lettuce and foodservice lettuce filets following notice of a produce industry ingredient recall by Adam Bros.
Farming Inc. Sandwich products bearing the Northwest Cuisine Creations and Fresh&Local labels. These prod- ucts are recalled because they may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7).
E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic...
Source: Food and Drug Administration - December 16, 2018 Category: Food Science Source Type: news
Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups ™
Apio, Inc. of Guadalupe, California is voluntarily recalling five SKUs of Eat Smart ® Single-Serve Salad Shake Ups™ (bowls). The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that one random sample of Eat Smart Single-Serve Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. (5.5oz) with Best Before of Dec 14, 2018 tested positive for Listeria Monocytogenes. As a precautionary measure, we are recalling all products produced on the same day, same production line, as the one sample that tested positive by CFIA. At this time, we are not aware of any illnesses linked by health officials t...
Source: Food and Drug Administration - December 16, 2018 Category: Food Science Source Type: news
