Log in to search using one of your social media accounts:

 

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricane’s Harvey and Irma
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA ’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricane’s Harvey and Irma (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 22, 2017 Category: American Health Source Type: news

Criminal and civil actions filed against Aegerion Pharmaceuticals Inc.
Aegerion Pharmaceuticals Inc. agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 22, 2017 Category: American Health Source Type: news

First Source Issues Allergy Alert On Undeclared Milk In Tasty Treats Nonpareils Milk Chocolate
First Source of Pico Rivera, CA, is recalling Tasty Treats Nonpareils Milk Chocolate 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 this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 21, 2017 Category: Food Science Source Type: news

Nature Supplement Inc. Issues Voluntary Florida Recall of Vegetable Vigra Due to Undeclared Sildenafil
Natures Supplement, Inc. is voluntarily recalling 260 bottles of VEGETABLE VIGRA, 200 mg capsules to the consumer level. FDA analysis found this product to be tainted with Sidenafil. Sildenafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of Sildenafil in the Vegetable Vigra product renders it an unapproved drug for which safety and efficacy has not been established, therefore subject to recall. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 20, 2017 Category: Food Science Source Type: news

Death Wish Coffee Co. Announces Recall of Nitro Cold Brew Cans From Retailers, Online Sales
Death Wish Co ffee Co. (“Death Wish”), the Round Lake, N.Y.-based coffee producer known for producing the ‘World’s Strongest Coffee’, has initiated a recall its 11-oz Death Wish Nitro Cold Brew cans. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 20, 2017 Category: Food Science Source Type: news

Gadget Island, Inc. Dba Gear Isle Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredients.
Newark, CA, Gadget Island, Inc. is voluntarily recalling to the consumer level. The products have been found to contain undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 20, 2017 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency ’s continued efforts to promote the safe adoption of medication-assisted treatment for opioid addiction
Medication-assisted treatment (MAT) – the use of medication combined with counseling and behavioral therapies – is one of the major pillars of the federal response to the opioid epidemic in this country. This type of treatment is an important tool that has the potential to help millions of Americans with an opioid use disorder reg ain control over their lives. In fact, patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration. Addressing the epidemic of opioid addiction is my highest public health priority. One element of t...
Source: Food and Drug Administration - September 20, 2017 Category: American Health Source Type: news

FDA clears first duodenoscope with disposable distal cap
The U.S. Food and Drug Administration today cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 20, 2017 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., about crops impacted by Hurricanes Harvey and Irma and FDA ’s work with farmers affected by the storms
Statement from FDA Commissioner Scott Gottlieb, M.D., about crops impacted by Hurricanes Harvey and Irma and FDA ’s work with farmers affected by the storms (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 14, 2017 Category: American Health Source Type: news

FDA approves new treatment for adults with relapsed follicular lymphoma
The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 14, 2017 Category: American Health Source Type: news

FDA approves first biosimilar for the treatment of cancer
The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 14, 2017 Category: American Health Source Type: news

Natural Grocers Issues Recall on Organic Deglet Dates Due to Mislabeling and Undeclared Allergens
Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand Organic Deglet Noor Dates Pitted because it may contain undeclared coconut, an allergen. People who have an allergy or severe sensitivity to coconut 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 - September 14, 2017 Category: Food Science Source Type: news

FDA permits marketing of mobile medical application for substance use disorder
Today, the U.S. Food and Drug Administration permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). The Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs. The application is not intended to be used to treat opioid dependence. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 14, 2017 Category: American Health Source Type: news

OriGen Biomedical Issues Nationwide Recall of OriGen VV28F Reinforced Dual Lumen ECMO Catheters
On August 2, 2017, OriGen Biomedical initiated a nationwide recall for two (2) lots of VV28F Reinforced Dual Lumen ECMO Catheters. These VV28F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub that it is inserted in, which potentially could result in required intervention to prevent permanent impairment/damage. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 13, 2017 Category: Food Science Source Type: news

Cherry Valley Marketplace Issues Allergy Alert on Undeclared Milk Allergens in “Cherry Valley Vanilla Cupcakes” and “Cherry Valley Chocolate Cupcakes”
Cherry Valley Marketplace, West Hempstead, NY, is recalling its 12-ounce packages of CHERRY VALLEY VANILLA CUPCAKES and CHERRY VALLEY CHOCOLATE CUPCAKES 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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 12, 2017 Category: Food Science Source Type: news

Medtronic Announces Voluntary Recall of Diabetes Infusion Sets
Medtronic plc (NYSE:MDT) announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 12, 2017 Category: Food Science Source Type: news

Bravo Produce Inc. Retira Maradol Papaya de Productores y Exportadores de Carica Papaya de Tecom án y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V. Por posible riesgo a la salud
Bravo Produce Inc de San Ysidro, est á retirando Maradol Papaya, cultivadas por Productores y Exportadores de Carica Papaya de Tecoman y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V., como manera preventiva, debido a que dicho producto ha probado positivo para Salmonella, es de suma importan cia mencionar que dicha bacteria puede afectar a niños, ancianos y personas con sistemas inmunológicos débiles. Los síntomas a experimentar son fiebre, diarrea, náusea, vómito y dolor abdominal. En raras circunstancias, la infección por Salm...
Source: Food and Drug Administration - September 12, 2017 Category: Food Science Source Type: news

Coborn ’s, Inc.’s Issues Recall of American Rye Bread and Caraway Rye Bread Due To Undeclared Allergens
Coborn's, Inc. is recalling packages of its American Rye Bread and Caraway Bread, which contain undeclared allergens (milk, soy and egg) as a result of an update to the ingredient profile from the manufacturer of the base. People who have an allergy or severe sensitivity to Milk, Soy, and/or Eggs 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 - September 11, 2017 Category: Food Science Source Type: news

Bravo Produce Inc. Recalls Maradol Papaya from Productores Y Exportadores De Carica Papaya De Tecom án Y Costa Alegre SPR of RL and Packed by Frutas Selectas De Tijuana, S. De R.L. De C.V. Because of Possible Health Risk
Bravo Produce Inc. of San Ysidro, is withdrawing Maradol Papaya, grown by Productores y Exportadores de Carica Papaya de Tecom án y Costa Alegre SPR of RL and packed by Frutas Selectas de Tijuana, S. de RL de CV, as a preventive measure, because the product has tested positive for Salmonella by exams done by FDA. It is extremely important to mention that this bacterium can affect children, elderly and people with weak immu ne systems. Symptoms are fever, diarrhea, nausea, vomiting and abdominal pain. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 10, 2017 Category: Food Science Source Type: news

Simply Fresh Foods, Inc. Issues Allergy Alert on Undeclared Milk in Single Serve Cups of San Francisco Seafood Salad Made with Greek Yogurt
Simply Fresh Foods, Inc. of Buena Park, CA is recalling 272 cases of one specific lot of its 4-4 ounce packages of " San Francisco Seafood Salad Made with Greek Yogurt " bearing a UPC bar code of 47502 19701 because the individual cups inside the carton may be mislabeled as Seafood Salad with Real Mayonnaise and does not declare " milk " . The outer carton is correct and has the correct ingredient statement which declares " milk " . People who have allergies to milk 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 - September 8, 2017 Category: Food Science Source Type: news

Garden of Life LLC Issues Recall of Baby Organic Liquid Formula
Today, Garden of Life, LLC, is issuing a voluntary precautionary recall of its new supplement for infants, Baby Organic Liquid, because the product, as labeled, includes directions for use that may be misinterpreted. The company is concerned that if not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 8, 2017 Category: Food Science Source Type: news

Product Recall By Wegmans Of Assorted Muffins 4 Pack
The assorted muffin four pack may include a banana nut muffin containing walnuts, an allergen not listed on the label. People who have an allergy or sensitivity to nuts should not consume this product. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 7, 2017 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy
(Source: Food and Drug Administration)
Source: Food and Drug Administration - September 7, 2017 Category: American Health Source Type: news

Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase & reg; (Alteplase)-100 mg Due to Lack of Sterility Assurance of the Sterile Water for Injection
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is voluntarily recalling three lots of Activase ® (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 7, 2017 Category: Food Science Source Type: news

Country Fresh Orlando LLC, Recalls Product Because of Possible Health Risk
Country Fresh Orlando, LLC. of Orlando, Florida, is recalling 5,999 cases of diced bell pepper, vegetable kabobs, and creole and fajita mixed diced vegetables (product descriptions attached), because they have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is 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 m...
Source: Food and Drug Administration - September 5, 2017 Category: Food Science Source Type: news

Wakefern Food Corp. Voluntarily Recalls ShopRite Semi-Sweet Real Chocolate Chips
Wakefern Food Corp. has initiated a voluntary recall of its ShopRite brand Semi-Sweet Real Chocolate Chips. The chips were sold in 24 oz. bags bearing a UPC bar code of 041190 02668 and Best if Used By dates of April 11, 2019 and April 12, 2019. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 1, 2017 Category: Food Science Source Type: news

PharMEDium Services, LLC Issues Voluntary Nationwide Recall of all unexpired lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose Due to Sub-Potency
PharMEDium Services, LLC (PharMEDium) is voluntarily recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose products that were produced between July 6, 2017 and August 29, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose which would lead to a lower dose being administered. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 1, 2017 Category: Food Science Source Type: news

FDA clears mammography device with option for patient-assisted compression
Today, the U.S. Food and Drug Administration cleared the first 2D digital mammography system that allows patients to increase or decrease the amount of compression applied to their own breast before the mammogram x-ray is taken. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 1, 2017 Category: American Health Source Type: news

FDA approves Mylotarg for treatment of acute myeloid leukemia
The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory). (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 1, 2017 Category: American Health Source Type: news

Hospira Issues Voluntary Worldwide Recall For Lots of Hydromorphone HCl Injection, USP, CII, (2 mg/mL) 1mg/mL Vial, and Levophed ® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial, Due to a Lack of Sterility Assurance
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed ® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. To date, Hospira, Inc., a Pfizer company has not received any reports of adverse events related to this recall. (Source: Food and Drug Administration)
Source: Food and Drug Administration - September 1, 2017 Category: Food Science Source Type: news

Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma
(Source: Food and Drug Administration)
Source: Food and Drug Administration - August 31, 2017 Category: American Health Source Type: news

Hospira Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial Due to The Presence of Particulate Matter Within a Single Vial
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 31, 2017 Category: Food Science Source Type: news

Mid Valley Pharmaceutical LLC Issues Voluntary Recall of Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup Due to Potential Contamination with Burkholderia Cepacia.
Mid Valley Pharmaceutical is recalling lot# 23221701 of Doctor Manzanilla Cough& Cold and lot# 23221701 of Doctor Manzanilla Allergy& Decongestant Relief syrup to the consumer level. The products may potentially be contaminated with the bacteria Burkholderia cepacia. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. To date, Mid Valley Pharmaceutical, LLC has not received any reports of adverse events related to this recall. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 30, 2017 Category: Food Science Source Type: news

Lucky Mart Inc. Issues Voluntary Nationwide Recall Of Piyanping Anti-Itch Lotion Due to Incorrect Active Ingredient
Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 30, 2017 Category: Food Science Source Type: news

Dedinas Franzak Enterprises Issues Allergy Alert On Undeclared Milk In " Butter Flavored Popcorn "
Dedinas Franzak Enterprises of Grand Rapids, MI, is recalling several brands of butter flavored popcorn 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 - August 30, 2017 Category: Food Science Source Type: news

Rajbhog Distributors GA Inc. Issues Allergy Alert on Undeclared Almonds in JALEBI
Rajbhog Distributors GA. Inc. of Tucker GA-30084 is recalling 1467 packets of Jalebi because it may contain undeclared Almond pcs. People who have an allergy or severe sensitivity to Almonds 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 - August 30, 2017 Category: Food Science Source Type: news

FDA approval brings first gene therapy to the United States
The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 30, 2017 Category: American Health Source Type: news

FDA approves new antibacterial drug
The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 29, 2017 Category: American Health Source Type: news

FDA approves first U.S. treatment for Chagas disease
The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 29, 2017 Category: American Health Source Type: news

Dedinas-Franzak Enterprises Issues Allergy Alert On Undeclared Milk In Big Win Butter Popcorn
Dedinas-Franzak Enterprises is recalling Big Win, Butter Popcorn Artificially Flavored 5 OZ, UPC #0-11822-58492-0, This product is artificially flavored and milk is not specifically called out in the Allergen Statement. The product may contain milk and people who have an allergy or severe sensitivity to Milk may run the risk of serious or life-threatening allergic reaction if they consume this product. The concern was identified through a non-illness consumer complaint in relation to flavor. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 28, 2017 Category: Food Science Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA ’ s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity ’ s most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine. The prospect of clinical tissue repair st...
Source: Food and Drug Administration - August 28, 2017 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA ’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold significant promise for transformative and potentially curative treatments for some of humanity ’s most troubling and intractable maladies. Recent advances in our basic knowledge of the pathways involved in tissue damage and regeneration have combined with remarkable progress in adult stem cell biology to put us at a genuine inflection point in the history of medicine. The prospect of clinic al tissue repair st...
Source: Food and Drug Administration - August 28, 2017 Category: American Health Source Type: news

FDA warns US Stem Cell Clinic of significant deviations
The U.S. Food and Drug Administration today posted a warning letter issued to US Stem Cell Clinic of Sunrise, Florida, and its Chief Scientific Officer Kristin Comella for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 28, 2017 Category: American Health Source Type: news

FDA acts to remove unproven, potentially harmful treatment used in ‘ stem cell ’ centers targeting vulnerable patients
The U.S. Food and Drug Administration took decisive action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California, and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. On behalf of the FDA, on Friday, Aug. 25, 2017 the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine, and althoug...
Source: Food and Drug Administration - August 28, 2017 Category: American Health Source Type: news

FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients
The U.S. Food and Drug Administration took decisive action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California, and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. On behalf of the FDA, on Friday, Aug. 25, 2017 the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine, and although...
Source: Food and Drug Administration - August 28, 2017 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA ’ s role in ensuring Americans have access to clear and consistent calorie and nutrition information; forthcoming guidance will provide greater clarity and certainty
As a doctor, father and the head of the U.S. Food& Drug Administration, I believe that everyone is entitled to the information they need to make informed decisions about the food they eat. We serve as the nation ’ s expert on food labeling, which is why Congress entrusted us with the responsibility of crafting predictable, uniform federal standards that will benefit the health of families across America by ensuring access to essential calorie and nutrition information on food and menu labels. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 25, 2017 Category: American Health Source Type: news

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA ’s role in ensuring Americans have access to clear and consistent calorie and nutrition information; forthcoming guidance will provide greater clarity and certainty
As a doctor, father and the head of the U.S. Food& Drug Administration, I believe that everyone is entitled to the information they need to make informed decisions about the food they eat. We serve as the nation ’s expert on food labeling, which is why Congress entrusted us with the responsibility of crafting predictable, uniform federal standards that will benefit the health of families across America by ensuring access to essential calorie and nutrition information on food and menu labels. (Source: Food and Drug Administration)
Source: Food and Drug Administration - August 25, 2017 Category: American Health Source Type: news

Cook Medical Issues Recall Correction of Zenith Alpha ™ Thoracic Endovascular Graft and Removes Specific Sizes from the Market
Cook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha ™ Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or “ transection ” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI. Cook also initiated a voluntary recall of Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device. These specific sizes are primarily used for BTAI, and are no longer available for purchase. (S...
Source: Food and Drug Administration - August 25, 2017 Category: Food Science Source Type: news

Cook Medical Issues Recall Correction of Zenith Alpha ™ Thoracic Endovascular Graft and Removes Specific Sizes from the Market
Cook Medical initiated a correction to the Instructions For Use (IFU) for the Zenith Alpha ™ Thoracic Endovascular Graft. This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI. C ook also initiated a voluntary recall of Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device. These specific sizes are primarily used for BTAI, and are no longer available for purchase. (So...
Source: Food and Drug Administration - August 25, 2017 Category: Food Science Source Type: news

Recall of Certain Frozen Organic Dark Sweet Pitted Cherry Products Due to Possible Contamination by Listeria Monocytogenes
Out of an abundance of caution, SunOpta Inc ’s subsidiary, Sunrise Growers Inc., has issued a voluntary recall of certain frozen organic dark sweet pitted cherry products due to 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. (S...
Source: Food and Drug Administration - August 23, 2017 Category: Food Science Source Type: news