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 […]
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.
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.
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. 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.
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.
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 […]
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 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. […]
Newark, CA, Gadget Island, Inc. is voluntarily recalling Rhino 7 Platinum 5000 capsules, All LOTS, Papa Zen 3300 capsules, LOT# NSS050888, Fifty Shades 6000 capsules, all Lots, Grande X 5800 capsules, all Lots, to the consumer level. FDA analysis has found the products to be tainted with Sildenafil and Tadalafil, which are the active ingredients […]
Sid Wainer & Son® of New Bedford, MA is voluntarily recalling Jansal Valley® brand Dried Chili De Arbol Peppers because it does not have the proper allergens identified, being peanuts. 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.
TAI FOONG USA of Seattle, WA is recalling Royal Asia Shrimp Wonton Noodle Soup, because it may contain undeclared EGG. People who have an allergy or severe sensitivity to Egg or egg products run the risk of serious or life-threatening allergic reaction if they consume these products. Individuals who are not allergic to eggs may […]
Impacts only the gallon-size Tropical Punch flavor of Tampico® bottled and distributed by Dean Dairy and sold in Illinois, Indiana and Wisconsin. All affected product has the “Best By” date of 12-27-17.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s Adverse Event Reporting System (FAERS) and new search tool
Hong Lee Trading Inc., NY, is recalling its VINA CAFÉ WAKE-UP INSTANT COFFEE MIX in 18 PACK CARDBOARD BOXES (.6 oz packs), with lot “EXP:17.MAR.2019 1T13.” because they 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.
Greencore, USA, LLC is voluntarily recalling egg salad sandwiches, ham salad sandwiches, and seafood stuffing as listed below. The products are being recalled because Listeria monocytogenes was found in environmental sampling conducted by FDA. Read The Complete Story!
Greencore, USA, LLC is voluntarily recalling egg salad sandwiches, ham salad sandwiches, and seafood stuffing as listed below. The products are being recalled because Listeria monocytogenes was found in environmental sampling conducted by FDA.
Chun Yuen Trading Co. of South El Monte, California, is recalling its 12.7 oz of 4-in-1 Reishi Coffee due to a mislabeling of the outer packaging, which contains undeclared milk content. People who are allergic to milk run the risk of serious or life threatening allergic reaction if they consume these products.
The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.