General Mills is voluntarily recalling two days of production of Cascadian Farm Organic Cinnamon Raisin Granola cereal because of an undeclared allergen. There have been no reports of illness.
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Great American Deli Issues Allergy Alert On Undeclared Egg And Soy In Premium Chicken Salad Wheatberry Sandwich
Great American Deli of Ooltewah, Tennessee is recalling 816 Premium Chicken Salad Wheatberry Sandwich Lot Number 17 198 because they have the wrong ingredient statement and contain undeclared eggs and soy. People who have an allergy or severe sensitivity to eggs or soy run the risk of serious or life-threatening allergic reaction if they consume these products.
Whole Foods Market Issues Nationwide Allergy Alert on Undeclared Peanuts in 365 Everyday Value Organic Raisin Bran
Whole Foods Market stores is voluntarily recalling 365 Everyday Value Organic Raisin Bran because the product contains undeclared peanuts that were not listed on the product label. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA approves implantable device to treat moderate to severe central sleep apnea
The U.S. Food and Drug Administration today approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. The Remedē System is an implantable device that stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing.
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s continued assistance following the natural disaster in Puerto Rico
FDA continues extensive efforts to provide direct assistance to the residents of Puerto Rico following Hurricanes Irma and Maria, and is taking new steps to mitigate the impact of these twin disasters on the island’s vibrant medical product manufacturing sector. Our top priority is the people of Puerto Rico.
Kiriko, LLC. Issues Voluntary Nationwide Recall of A1 Slim Due to Undeclared Sibutramine, Phenolphthalein and N-Desmethyl sibutramine
, Kiriko, LLC. is voluntarily recalling all lots of A1 Slim 30 capsules bottle to the consumer level. FDA laboratory analysis has found the A1 Slim product to be tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.
FDA awards 15 grants for clinical trials to stimulate product development for rare diseases
The U.S. Food and Drug Administration today announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country.
FDA awards six grants for natural history studies in rare diseases
The U.S. Food and Drug Administration today announced it has awarded six new research grants for natural history studies in rare diseases. The aim of the research is to inform medical product development by better understanding how specific rare diseases progress over time. One potential application of these studies is the opportunity to eventually use natural history models to augment the need for placebo arms in studies of drugs that target very rare disease, where trial recruitment can be challenging.
FDA approves first test for screening Zika virus in blood donations
The U.S. Food and Drug Administration today approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors.
Baxter Initiates Voluntary Nationwide Recall of One Shipment of Intralipid 20% IV Fat Emulsion Due to Product Being Exposed to Subfreezing Temperatures
Baxter International Inc. announced today it is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100 mL, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the United States, to the user level. The product has been exposed to subfreezing temperatures during transit to a distribution facility. The subfreezing temperature is outside of the acceptable storage range listed on the product labeling. Other shipments of this lot are not affected by this issue.