Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency ’ s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products
FDA is taking new steps to strengthen agency ’ s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 27, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency ’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products
FDA is taking new steps to strengthen agency ’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 27, 2019 Category: American Health Source Type: news
FDA advances landmark policy changes to modernize mammography services and improve their quality
FDA proposes landmark policy changes to modernize mammography services and improve their quality (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 27, 2019 Category: American Health Source Type: news
FDA approves new oral drug to treat multiple sclerosis
The U.S. Food and Drug Administration today approved Mayzent (siponimod) tablets to treat adults with
relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 26, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility
The FDA is aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility. The EPA order was due to the presence of levels of ethylene oxide higher than the EPA found to be acceptable in air around the facility. The FDA has been closely monitoring the situation and working with device manufacturers affected by the closure to minimize any impact to patients who need access to these medical devices. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 26, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA ’ s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., on efforts to promote and foster blood pathogen reduction technologies
FDA statement on efforts to promote and foster blood pathogen reduction technologies (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 26, 2019 Category: American Health Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA ’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., on efforts to promote and foster blood pathogen reduction technologies
FDA statement on efforts to promote and foster blood pathogen reduction technologies (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 26, 2019 Category: American Health Source Type: news
USA LESS Issues Voluntary Nationwide Recall of LEOPARD Miracle Honey Due to Presence of Undeclared Sildenafil
USA LESS, is voluntarily recalling all lots of LEOPARD Miracle Honey, to the consumer level. FDA analysis has found LEOPARD Miracle Honey to be tainted with sildenafil. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 25, 2019 Category: Food Science Source Type: news
Henry Avocado Recalls Whole Avocados Because Of Possible Health Risk
Henry Avocado Corporation is voluntarily recalling California-grown whole avocados sold in bulk at retail stores because they have the potential to be contaminated with Listeria monocytogenes. Henry Avocado is issuing this voluntary recall out of an abundance of caution due to positive test results on environmental samples taken during a routine government inspection at its California packing facility. There are no reported illnesses associated with this recall. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 24, 2019 Category: Food Science Source Type: news
Ata Int. Inc. Issues Voluntary Nationwide Recall of BLUEFUSION Capsules, due to presence of Undeclared Sildenafil, Tadalafil, Desmethyl carbodenafil, Dithiodesmethyl carbodenafil, Scutellarin and Daidzein
Ata Int. Inc. is voluntarily recalling all lots within expiry of BLUEFUSION Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzein. Sildenafil and tadalafil are FDA approved drugs for the treatment of male erectile dysfunction and are in a class of drugs called phosphodiesterase (PDE-5) inhibitors. Desmethyl carbodenafil and dithiodesmethyl carbodenafil are analogues of PDE-5 inhibitors and are likely to have the same pharmacological activity as PDE-5 inhibitors and thus carry the same clinic...
Source: Food and Drug Administration - March 21, 2019 Category: Food Science Source Type: news
Hill ’s Pet Nutrition Expands Voluntary Recall of Select Canned Dog Food for Elevated Vitamin D
Hill ’s Pet Nutrition today announced it is expanding its recall of select canned dog food products due to elevated levels of vitamin D. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 21, 2019 Category: Food Science Source Type: news
FDA approves new device for treating moderate to severe chronic heart failure in patients
Device to treat heart failure was given Breakthrough Device designation because it treats a life-threatening disease and addresses unmet clinical need. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 21, 2019 Category: American Health Source Type: news
Better Made Snack Foods Issues Allergy Alert on Undeclared Milk In 10 Ounce $3.99 Original Potato Chips
The recall was initiated after it was discovered that a package of 10-ounce Original Potato Chips dated 10 AUG 2019 did not contain Original Potato Chips but instead contained Cheddar and Sour Cream Potato Chips which contain milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company ' s production and packaging processes which may have affected 660 bags of 10-ounce Original Potato Chips. (Source: Food and Drug Administration)
Source: Food and Drug Administration - March 21, 2019 Category: Food Science Source Type: news
Century Snacks LLC Recalls Snak Club Honey Bliss Nut Mix Due to Undeclared Allergen
Century Snacks, LLC of Commerce, CA is recalling all packages of 3-oz. and 5.75-oz. SNAK CLUB HONEY BLISS NUT MIX due to undeclared MILK. People who have an allergy or severe sensitivity to MILK 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 - March 21, 2019 Category: Food Science Source Type: news
Kingston Pharma, LLC RECALLS " DG ™/health NATURALS baby Cough Syrup + Mucus” Because of Possible Health Risk
Kingston Pharma, LLC of Massena, NY is recalling Lot KL180157 of its 2-fluid ounce (59 mL) bottles of DG ™/health NATURALS baby Cough Syrup + Mucus” because it has the potential to be contaminated with Bacillus cereus/ Bacillus circulans. Bacillus cereus in food products has the potential to produce two forms of gastrointestinal illness, one being a syndrome primarily of vomiting, and the other of diarrhea. Most often, illnesses are mild and self-limiting, although more serious and even lethal cases have occurred. Individuals at risk for more severe forms of illness include infants, young children, and others with weak...
Source: Food and Drug Administration - March 20, 2019 Category: Food Science Source Type: news
