Archive for the ‘Food & Drug Recalls’ category

ANF Pet Inc. Issues Voluntary Precautionary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D

November 28, 2018

ANF, Inc. is issuing a voluntary recall of select products of ANF Pet Lamb and Rice Dog Food (reference below) due to potentially elevated levels of Vitamin D.

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk

November 28, 2018

Sprout Creek Farm of Poughkeepsie, New York is recalling 4 wheels of “Kinkead” cheese made on 5-10-18, because it has 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 […]

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

November 28, 2018

The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

November 28, 2018

The FDA approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

Allergen Alert: Kitchen Cravings Strawberry and Mixed Berry Parfaits with Trace Tree Nuts

November 27, 2018

Kwik Trip, Inc. located in La Crosse, WI is recalling Kitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup because they may contain undeclared traces of cashews or almonds Read The Complete Story!

Achdut Recalls Multiple Brands of "Tahini" Because It May Be Contaminated with Salmonella

November 27, 2018

Achdut LTD. of Ariel, Israel, is recalling its Tahini products of all packages and sizes produced on the following dates: April 7th to May 21st 2018, because it may 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 […]

Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway

November 27, 2018

FDA Commissioner statement on modernizing the 510(k) pathway by creating policies that rely on newer predicates with modern characteristics related to their safety and performance

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

November 27, 2018

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity […]

Sunshine Mills, Inc. Issues Voluntary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D

November 27, 2018

Sunshine Mills, Inc. is issuing a voluntary recall of select products of Evolve Puppy, Sportsman’s Pride Large Breed Puppy and Triumph Chicken and Rice Dog Food (reference below) due to potentially elevated levels of Vitamin D. Read The Complete Story!

Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products

November 27, 2018

FDA scientists tested 26 separate kratom products and found lead and nickel at levels not considered safe for human consumption

FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients

November 27, 2018

FDA issues a warning to consumers to beware of and avoid certain male enhancement products that may be dangerous to their health

Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation

November 26, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation

FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

November 26, 2018

The FDA granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker).

Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of Six Lots of Thermacare® Heatwraps Due to Leaking Wraps With The Potential For Skin Injuries

November 26, 2018

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling six lots of ThermaCare® HeatWrap product to the consumer level. Pfizer Consumer Healthcare initiated this recall because product from these lots has a potential to leak ingredients that are contained in the heat cell wrap.

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices

November 26, 2018

FDA provides updates on two elements in medical device safety action plan: modernizing 510(k) program and new process for establishing special controls.

Ottogi America, Inc. Issues Allergy Alert on Undeclared Egg in Product

November 24, 2018

Ottogi America, Inc. of Gardena, California announced today it is recalling 1lb 5.16ounce of Jin Ramen Mild 5pk. (Best Before Aug. 19th 2019) and Jin Ramen Spicy 5pk. (Best Before Aug. 20th 2019) due to undeclared egg as an ingredient on the packages. People who have an allergy or severe sensitivity to eggs run the […]

FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions

November 23, 2018

Beckman Coulter Life Sciences today announced the previously communicated global voluntary recall launched in January 2018 related to the FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Software (together referred to as the EPICS) has been classified as Class 1 by the U.S. Food […]

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

November 21, 2018

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do […]

FDA approves new treatment for patients with acute myeloid leukemia

November 21, 2018

The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive […]

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