Archive for the ‘Food & Drug Recalls’ category

Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling

July 27, 2017

Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been recalled due to a potential mislabeling. […]

Grande Produce Issues Voluntary Recall of Limited Quantity of Papaya “Caribeña” Due to Potential Health Risk

July 26, 2017

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.

Hy-Vee, Inc. Issues Allergy Alert on Undeclared Soy in Hy-Vee Brand Pizzas

July 26, 2017

Hy-Vee, Inc. based in West Des Moines, Iowa, is voluntarily recalling eight Hy-Vee brand pizzas that were sold at its six Minneapolis-area stores because they may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA Investigates Multiple Salmonella Outbreak Strains Linked to Papayas

July 25, 2017

Please find more information about the Outbreak of Salmonellosis Linked to Papaya here:

Cantrell Drug Company Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance

July 25, 2017

Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and Vermont. To date, Cantrell has not received any reports of […]

EZ Weight Loss TX LLC Issues Voluntary Nationwide Recall of Atomic and Xplode Capsules Due to the Presence of Undeclared Sibutramine

July 24, 2017

Corpus Christi, TX, EZ Weight Loss TX is voluntarily recalling all lots of La Bri’s Body Health Atomic and Xplode capsules to the consumer level. FDA analysis has found the products to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons. The […]

The Idaho Foodbank Recalls Coconut Beverage, Broccoli Cheddar Soup, Eggs, and Cheese Product Because Of Possible Health Risk

July 21, 2017

The Idaho Foodbank is recalling approximately 27,000 pounds of Coconut Beverage, Broccoli Cheddar Soup, Eggs, and Cheese Product. These products are being recalled because they were not continuously maintained or stored at the required temperature due to a malfunction in the cooler. This could result in contamination by spoilage organisms or pathogens, which could lead […]

Bhu Foods Voluntarily Recalls Protein Bars for Possible Health Risk

July 21, 2017

Hudson Valley Foods, Inc. of Highland, NY has advised Bhu Foods of San Diego, CA that organic sunflower seeds sold to the company have been recalled. As a result of a recall of sunflower seeds from Hudson Valley Foods, Inc.,Bhu Foods’ supplier of organic sunflower seeds, advised Bhu Foods that ingredients sold to the company […]

Ultra Shop Supplement Issues Voluntary Nationwide Recall of Super Panther 7K Due to Presence of Undeclared Sildenafil and Tadalafil

July 21, 2017

Charlotte, NC, Ultra Shop Supplement is voluntarily recalling Super Panther 7K capsules, [1 count blister card Lot#: RO846356 and 6 count bottle Lot RO246852 within expiry], distributed by SX Power Co., Brooklyn, NY, to the consumer level. FDA analysis found samples of Super Panther 7K to be tainted with undeclared sildenafil and tadalafil, active ingredients […]

FDA clears first neonatal magnetic resonance imaging device

July 20, 2017

Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU).

Statement from FDA Commissioner Scott Gottlieb, M.D., on the Funding Awards to States for FDA Food Safety Modernization Act (FSMA) Produce Safety Implementation

July 19, 2017

More than 3,000 Americans are estimated to die each year from foodborne illnesses and many more are hospitalized and sickened. Yet most of these illnesses and deaths are preventable. While the U.S. has one of the safest food supplies in the world, Congress entrusted the FDA with new authorities and resources – as part of […]

FDA approves Vosevi for Hepatitis C

July 18, 2017

The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.

Garden of Light Inc. Recalls Woodstock Organic Matcha Vanilla Oats Because of Possible Health Risk

July 18, 2017

Garden of Light, Inc. dba Gluten Free Solutions of East Hartford, CT, is voluntarily recalling the Woodstock Organic Matcha Vanilla Oats, 1.8 oz. which is manufactured by Garden of Light for Blue Marble Brands. The product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections […]

FDA approves new treatment to reduce the risk of breast cancer returning

July 17, 2017

The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. […]

Bestherbs Coffee LLC Issues Voluntary Nationwide Recall of New Kopi Jantan Tradisional Natural Herbs Coffee due to the Presence of Undeclared Active Pharmaceutical Ingredients and Undeclared Milk

July 17, 2017

Grand Priarie, TX, Bestherbs Coffee LLC is voluntarily recalling all lots of New of Kopi Jantan Tradisional Natural Herbs Coffee, 13 grams to the consumer level. FDA laboratory analysis confirmed the presence of desmethyl carbodenafil. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction (ED). […]

Texas Legend Foods Issues Allergy Alert on Undeclared Cheese, Milk & Egg in "Silver Star Chipotle Dip"

July 14, 2017

Texas Legend Foods of Austin, TX, is recalling its 16 ounce jars of Silver Star Chipotle Queso Dip because they contain undeclared cheese, milk and eggs. People who have allergies to cheese, milk and eggs run the risk of a serious or life-threatening allergic reaction if they consume this product.

Statement from FDA Commissioner Scott Gottlieb, M.D., on National Academies of Sciences, Engineering, and Medicine report on pain management and prescription opioid abuse

July 13, 2017

In March 2016, the FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to outline the state of the science regarding prescription opioid abuse and misuse, as well as the evolving role that opioids play in pain management. We greatly appreciate all the work done by NASEM over the past year to produce […]

Statement from Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and Radiological Health on the status of FDA’s investigation into inaccurate results from certain lead tests

July 13, 2017

On May 17, the U.S. Food and Drug Administration warned Americans that Magellan Diagnostics’ LeadCare test systems performed on blood drawn from the vein (venous) may provide inaccurate results.

Sunneen Health Foods Issues Recall of Parfait Due to Undeclared Allergens

July 12, 2017

Sunneen Health Foods is voluntarily recalling mislabeled Whole Foods Market PB&J parfaits sold at five Whole Foods Market stores in New York and New Jersey because the products contained soy and tree nut (almond and coconut) allergens that were not listed on the product label. People who have an allergy or severe sensitivity to soy […]

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