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Food Co. Issues Allergy Alert on Undeclared Allergen (E.G. Milk) in Product
Colorado Nut Company of Denver, CO is recalling Cashew Cranberry Cherry Jubilee, Oat Bran Nutty Crunch, Honey Nutty Granola, Peanut Delight, and Frontier Trail Mix, because they 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 these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 22, 2017 Category: Food Science Source Type: news

FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients
FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens ’ power after cataract surgery so that the patient will have better vision when not using glasses. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 22, 2017 Category: American Health Source Type: news

FDA approves first two-drug regimen for certain patients with HIV
FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 21, 2017 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse
FDA Commissioner on steps to promote development of generic versions of opioids formulated to deter abuse (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 21, 2017 Category: American Health Source Type: news

Goya Voluntary Recall of Adobo Because of Possible Health Risk
Goya de Puerto Rico is recalling 28 ounces Adobo with Cumin Seasoning and 28 ounces Adobo with Pepper Seasoning because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune system. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 21, 2017 Category: Food Science Source Type: news

Casa Sanchez Foods Extiende El Retiro Voluntario Del " Real Guacamole " Para Incluir “ Spicy Guacamole ” Del Mercado Por Causa De Posible Riesgo Para La Salud
Casa Sanchez Foods de Hayward, California, est á retirando todo su " Real Guacamole " y “ Spicy Guacamole ” del mercado, por precauci ó n de acuerdo con el compromiso de la compa ñ í a para proteger la salud p ú blica. La retirada fue necesaria por los resultados de pruebas positivas para Listeria monocytogenes en dos paquetes de muchas muestras recogidas para el programa de pruebas de muestras aleatorias de la Administraci ó n de Drogas y Alimentos de EE. UU. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 18, 2017 Category: Food Science Source Type: news

Expanded Voluntary Recall for Casa Sanchez Foods " Real Guacamole " and to also Include “ Spicy Guacamole ” Because of Possible Health Risk
Casa Sanchez Foods of Hayward, CA, is voluntarily recalling all " Real Guacamole " and “ Spicy Guacamole ” products out of an abundance of caution in keeping with the company ’ s commitment to protect the public health. The recall was necessitated by positive test results for Listeria monocytogenes on two packages out of many samples collected for the U. S. Food and Drug Administration random sample testing program. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 18, 2017 Category: Food Science Source Type: news

Casa Sanchez Foods Extiende El Retiro Voluntario Del " Real Guacamole " Para Incluir “Spicy Guacamole” Del Mercado Por Causa De Posible Riesgo Para La Salud
Casa Sanchez Foods de Hayward, California, est á retirando todo su " Real Guacamole " y “Spicy Guacamole” del mercado, por precaución de acuerdo con el compromiso de la compañía para proteger la salud pública. La retirada fue necesaria por los resultados de pruebas positivas para Listeria monocytogenes en dos paquetes de muchas muestras recogidas para el programa de pruebas de muestras aleatorias de la Administración de Drogas y Alimentos de EE. UU. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 18, 2017 Category: Food Science Source Type: news

Expanded Voluntary Recall for Casa Sanchez Foods " Real Guacamole " and to also Include “Spicy Guacamole” Because of Possible Health Risk
Casa Sanchez Foods of Hayward, CA, is voluntarily recalling all " Real Guacamole " and “Spicy Guacamole” products out of an abundance of caution in keeping with the company’s commitment to protect the public health. The recall was necessitated by positive test results for Listeria monocytogenes on two packages out of many samples collected for the U. S. Food and Drug Administrat ion random sample testing program. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 18, 2017 Category: Food Science Source Type: news

FDA approves first telehealth option to program cochlear implants remotely
FDA approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 17, 2017 Category: American Health Source Type: news

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls
Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts by the agency to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 17, 2017 Category: American Health Source Type: news

Greenstone Issues Voluntary Nationwide Recall of Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP Due to Possible Sub Potent and Super Potent Tablets
For Immediate Release – PEAPACK, NJ, November 16, 2017 - Greenstone LLC, a wholly owned subsidiary of Pfizer Inc., is voluntarily recalling multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP to the consumer level. Greenstone initiated this recall because product from these lots has the pote ntial to be super potent or sub potent. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 16, 2017 Category: Food Science Source Type: news

Lipari Foods, LLC. Issues Voluntary Product Recall of Specific Dark Chocolate Products Due to Undeclared Milk Allergen
Lipari Foods, LLC has issued a voluntary recall of specific dark chocolate products packaged by sister company JLM due to an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products. The products are safe for consumption by those who do not have an allergy or severe sensitivity to milk. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 16, 2017 Category: Food Science Source Type: news

FDA expands approval of Sutent to reduce the risk of kidney cancer returning
FDA approves first adjuvant treatment for adult patients who are at a high risk of kidney cancer returning after a kidney has been removed. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 16, 2017 Category: American Health Source Type: news

FDA approves new treatment to prevent bleeding in certain patients with hemophilia A
FDA approves new treatment to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have Factor VIII inhibitors. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 16, 2017 Category: American Health Source Type: news

Giant/Martin ’ s Alerts Customers to Voluntary Recall of Store Brand Frozen Whole Kernel Sweet Corn
GIANT Food Stores, LLC and MARTIN ’ S Food Markets announced it removed from sale GIANT/MARTIN ’ S Brand Frozen Whole Kernel Sweet Corn due to potential Listeria monocytogenes contamination. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 16, 2017 Category: Food Science Source Type: news

Giant/Martin ’s Alerts Customers to Voluntary Recall of Store Brand Frozen Whole Kernel Sweet Corn
GIANT Food Stores, LLC and MARTIN ’S Food Markets announced it removed from sale GIANT/MARTIN’S Brand Frozen Whole Kernel Sweet Corn due to potential Listeria monocytogenes contamination. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 16, 2017 Category: Food Science Source Type: news

Giant Food Alerts Customers to Voluntary Recall of Store Brand Frozen Whole Kernel Sweet Corn
Giant Food, LLC announced it removed from sale Giant Brand Frozen Whole Kernel Sweet Corn due to potential Listeria monocytogenes contamination. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 16, 2017 Category: Food Science Source Type: news

Stop & Shop Alerts Customers to Voluntary Recall of Store Brand Frozen Whole Kernel Sweet Corn
The Stop& Shop Supermarket Company LLC announced it removed from sale Stop& Shop Brand Frozen Whole Kernel Sweet Corn due to potential Listeria monocytogenes contamination. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 16, 2017 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA ’ s comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health
Commissioner statement on FDA ’ s comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 16, 2017 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA ’s comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health
Commissioner statement on FDA ’s comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 16, 2017 Category: American Health Source Type: news

FDA announces comprehensive regenerative medicine policy framework
to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 16, 2017 Category: American Health Source Type: news

Casa Sanchez Foods Recalls " Real Guacamole " Because Of Possible Health Risk
Casa Sanchez Foods of Hayward, CA, is recalling its 9-ounce containers of " Real Guacamole " because they have the potential to be contaminated with Listeria monocytogenes, 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 - November 16, 2017 Category: Food Science Source Type: news

Yorgo ’s Foods Inc Is Recalling All Flavored and Unflavored Food Products (Hommus; Tahini Sauces; Yogurt Dip, Salads, Tzatziki, Grape Leaves; Taboule) Due to Possible Health Risk
Yorgo ’s Foods Inc. of Manchester NH, a family-owned company, started in 1993, is recalling all Greek-style food products it manufactures, out of an abundance of caution, as they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal in fections in pregnant women, young children, frail or elderly people, those with weakened immune systems and in unborn fetuses. 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 ...
Source: Food and Drug Administration - November 16, 2017 Category: Food Science Source Type: news

FDA unveils a streamlined path for the authorization of tumor profiling tests alongside its latest product action
Newly authorized test detects genetic cancer mutations in 468 unique genes (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 15, 2017 Category: American Health Source Type: news

FDA approves treatment for rare genetic enzyme disorder
(Source: Food and Drug Administration)
Source: Food and Drug Administration - November 15, 2017 Category: American Health Source Type: news

FDA grants marketing authorization of the first device for use in helping to reduce the symptoms of opioid withdrawal
FDA permits marketing of the first device for use in helping to reduce the symptoms of opioid withdrawal (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 15, 2017 Category: American Health Source Type: news

Baxter Issues A Voluntary Nationwide Recall For One Lot of Nexterone Injection Due To Presence Of Particulate Matter
Baxter International Inc. announced today it is voluntarily recalling one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection – distributed between 6/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities – due to the potential presence of particulate matter. The particulate matter may have entered the solution during the manufacturing process. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 14, 2017 Category: Food Science Source Type: news

FDA warns about illegal use of injectable silicone for body contouring and associated health risks
FDA issues safety communication about illegal use of injectable silicone for body contouring and associated health risks (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 14, 2017 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA advisory about deadly risks associated with kratom
A botanical substance known as kratom has raised significant concerns given its increasing prevalence and potential safety risks. The FDA has issued a public health advisory related to mounting concerns regarding risks associated with the use of kratom. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 14, 2017 Category: American Health Source Type: news

FDA approves pill with sensor that digitally tracks if patients have ingested their medication
The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 14, 2017 Category: American Health Source Type: news

Seattle Gourmet Foods Issues Allergy Alert on Undeclared Almonds In 5 Pound Bags of Dilettante Chocolates Espresso Blend
Seattle Gourmet Foods of Kent, Washington is recalling 127 cases of Costco item # 2335, Dilettante Chocolates Espresso Blend, Espresso Beans in Semisweet, Milk and White Chocolate, because it may contain undeclared almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 13, 2017 Category: Food Science Source Type: news

Nestle USA Initiates Voluntary Recall of Hot Pockets ® Four Cheese Pizza Snack Bites Due to Undeclared Allergens
Nestl é USA has initiated a recall of Hot Pockets ® Four Cheese Pizza Snack Bites due to misbranding and undeclared allergens. The product was donated to a charitable organization in Missouri and was not sold in retail. The product contain the known allergens egg, milk, soy, and wheat, which are not declared. People who have an allergy or severe sensitivity to eggs, milk, soy or wheat run the risk of serious or life-threatening allergic reaction if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 13, 2017 Category: Food Science Source Type: news

Nestle USA Initiates Voluntary Recall of Hot Pockets ® Four Cheese Pizza Snack Bites Due to Undeclared Allergens
Nestl é USA has initiated a recall of Hot Pockets® Four Cheese Pizza Snack Bites due to misbranding and undeclared allergens. The product was donated to a charitable organization in Missouri and was not sold in retail. The product contain the known allergens egg, milk, soy, and wheat, which are not decl ared. People who have an allergy or severe sensitivity to eggs, milk, soy or wheat run the risk of serious or life-threatening allergic reaction if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 13, 2017 Category: Food Science Source Type: news

Yorgo Foods Inc is Recalling Various Flavors of Hommus Because of Possible Health Risk
Yorgo Foods Inc of Manchester NH, is recalling select varieties of Hommus and Baba Ghannouj, because they have the potential to be contaminated with Listeria monocytogenes, 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 - November 11, 2017 Category: Food Science Source Type: news

Figi ’s Issues Recall Alert Due to Undeclared Allergen (Milk) in Dark Chocolate Gingersnaps
Figi ’s Companies, Inc of Marshfield, WI is recalling the following 2 products that are related to the GKI FOODS LLC Dark Chocolate Products recall because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life- threatening all ergic reaction if they consume these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 9, 2017 Category: Food Science Source Type: news

GKI Issues Allergy Alert On Undeclared Milk In Dark Chocolate Almond Bark
Germack Roasting Co, is recalling its 5 ounce and 1lb packages of Germack Dark Chocolate Almond Bark because they may contain undeclared milk. People who have allergies 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 - November 9, 2017 Category: Food Science Source Type: news

Kroger Stores Issue Allergy Alert on Dark Chocolate Products due to Undeclared Milk
Kroger stores in Michigan are recalling select bulk dark chocolate products following the GKI Foods LLC recall of dark chocolate products due to an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 8, 2017 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access
To further streamline the submission and review process for shared system REMS (for any REMS that includes more than one medication), today the FDA is releasing a draft guidance for industry, Use of a Drug Master File for Shared System REMS Submissions, that describes how applicants can submit collective sets of files to the FDA that represent all participating firms. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 8, 2017 Category: American Health Source Type: news

Nature ’ s Touch Frozen Foods Voluntarily Recalls Nature ’ s Touch Frozen Organic Fine Whole Green Beans Because of Possible Health Risk
Nature ’ s Touch Frozen Foods LLC. of Front Royal, Virginia is voluntarily recalling one product, Nature ’ s Touch Frozen Organic Fine Whole Green Beans, due to potential contamination with Listeria monocytogenes. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 8, 2017 Category: Food Science Source Type: news

Nature ’s Touch Frozen Foods Voluntarily Recalls Nature’s Touch Frozen Organic Fine Whole Green Beans Because of Possible Health Risk
Nature ’s Touch Frozen Foods LLC. of Front Royal, Virginia is voluntarily recalling one product, Nature’s Touch Frozen Organic Fine Whole Green Beans, due to potential contamination with Listeria monocytogenes. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 8, 2017 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on a practical approach to ensuring timely implementation of FDA ’ s menu labeling rule
FDA menu labeling guidance (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 7, 2017 Category: American Health Source Type: news

United Natural Trading LLC Announces Voluntary Recall of Dark Chocolate Almonds and Dark Chocolate Cashew Due to Possible Health Risk From an Undeclared Milk Allergen
United Natural Trading LLC, Edison, NJ, is voluntarily recalling Dark Chocolate Cashews and Dark Chocolate Almonds (see below) sold under the Woodstock, Market Basket, Lunds and Byerlys brands due to a possible health risk from an undeclared milk allergen. 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 - November 6, 2017 Category: Food Science Source Type: news

FDA clears common blood cell count test that offers faster results for patients and providers
The U.S. Food and Drug Administration today cleared a complete blood cell count (CBC) test that, based on its categorization, can be run in more health care settings, including physicians ’ offices, clinics or other types of health care facilities, by a wider range of personnel (e.g. support staff). This broadened test access will allow for faster availability of results. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 6, 2017 Category: American Health Source Type: news

Dutch Valley Food Distributors Inc. ISSUES ALLERGY ALERT ON UNDECLARED MILK IN Item # 050605 12/11oz Dark Chocolate Almonds and Item # 050601 12/11oz Dark Chocolate Cashews.
Dutch Valley Food Distributors Inc. of Myerstown, PA is recalling 11oz Dark Chocolate Almonds and 11oz Dark Chocolate Cashews, because it contains 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 - November 6, 2017 Category: Food Science Source Type: news

FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer
FDA expands approval of Zelboraf (vemurafenib) to include treatment of certain adult patients with Erdheim-Chester Disease, a rare blood cancer. This is the first FDA-approved treatment for ECD. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 6, 2017 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency ’ s streamlined development and review pathway for consumer tests that evaluate genetic health risks
Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency ’ s streamlined development and review pathway for consumer tests that evaluate genetic health risks (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 6, 2017 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency ’s streamlined development and review pathway for consumer tests that evaluate genetic health risks
Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency ’s streamlined development and review pathway for consumer tests that evaluate genetic health risks (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 6, 2017 Category: American Health Source Type: news

DSD Merchandisers, Inc. Voluntary Recalls Dark Chocolate Almond Products Due to Undeclared Milk Allergen
In cooperation with the GKI Foods LLC recall of Dark Chocolate Almonds due to an undeclared milk allergen, DSD Merchandisers, Inc., Livermore, CA, is voluntarily recalling bulk Dark Chocolate Almonds and pre-packaged Dark Chocolate Almonds. All lot numbers are affected. This recall is an extension of the GKI Foods LLC recall announced on October 27, 2017. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 3, 2017 Category: Food Science Source Type: news

Ridge Properties DBA Pain Relief Naturally Issues Voluntary Nationwide Recall of all lots of Naturally HL Bedsore Cream, Pretat by TAT Balm Carbomer Free Gel, & All Naturally HL Hemorrhoid products due to manufacturing concerns at the facility
Ridge Properties DBA Pain Relief Naturally is voluntarily recalling all lots within expiry of Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT Balm Carbomer Free Gel and Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine manufactured by Ridge Properties dba Pain Relief Naturally, Salem, Oregon to the consumer level. These products are being recalled after an FDA inspection found significant violations of current good manufacturing practice regulations. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 3, 2017 Category: Food Science Source Type: news