Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies, including three disease specific draft guidances
Federal judge enters consent decree against Minnesota dairy farm for drug residue violations
Federal judge enters consent decree against Minnesota dairy farm for drug residue violations
FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions
FDA is requiring safety labeling changes for fluoroquinolones to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances.
FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product
FDA granted an EUA to DOD to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma (referred to as French FDP).
Statement by FDA Commissioner Scott Gottlieb, M.D., on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids
FDA Commissioner statement on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem opioid misuse and abuse.
Pseudomonas Aeruginosa Bacteria Found In Saje Splish Splash Gentle Baby Wash
Saje Natural Wellness is warning customers not to use Splish Splash Gentle Baby Wash, 8.5 fl. oz. and 1.7 fl. oz. (found in the Wee and Well Gentle Baby Care Kit) as it may contain the bacteria Pseudomonas aeruginosa. Pseudomonas aeruginosa is an opportunistic pathogen that causes infection and results in bacteria in the blood, particularly in individuals with compromised immune systems.
Radagast Pet Food, Inc. Voluntarily Recalls Three Lots of Rad Cat Raw Diet Free-Range Chicken Recipe and One Lot of Pasture-Raised Venison Recipe Because of Possible Health Risk
Radagast Pet Food, Inc. of Portland, OR is recalling three lots of Rad Cat Raw Diet Free-Range Chicken Recipe because testing results indicate they have the potential to be contaminated with Listeria monocytogenes. The Company is also recalling one lot of Rad Cat Raw Diet Pasture-Raised Venison Recipe because testing results indicate it has the potential to be contaminated with Shiga Toxin producing E. coli O121. This recall is being conducted out of an abundance of caution. Due to Radagast Pet Food’s commitment to food safety and quality, The Company is conducting this voluntary recall.
LL’S Magnetic Clay Inc. Expands Allergy Alert On Undeclared Allergens In Prescript-Assist Dietary Supplement To All Lots
LL’s Magnetic Clay, Inc. of Austin, Texas is recalling all lots of Prescript-Assist (still within expiration date), a dietary supplement it marketed until late 2017, because of its potential to contain undeclared allergens, including almonds, crustaceans, milk, casein, eggs, and peanuts. People who have an allergy or severe sensitivity to these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products.
United States Bakery Issues Allergy Alert On Undeclared Milk In Naked Bread Hamburger Buns
United States Bakery of Portland, Oregon is recalling Naked Bread Hamburger Buns #NothingToHide, 8 pack, affected lot codes F6 Best By June 16th, 2018 through July 16th 2018, because it may contain 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 this product.
May Flower International Inc. Issues a Allergy Alert on Undeclared Milk Allergens in “3+2 Soda Crackers”
May Flower International Inc. of 5672 49th Place, Maspeth, NY, is recalling its 4.4 ounce
packages of “3+2 Soda Crackers” because they may contain undeclared milk allergens.
Consumers who are allergic to milk allergens may run the risk of serious or life threatening allergic reactions if they consume this product.