Today the U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test. Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death.
U.S. Marshals seize drug products from Flawless Beauty
Various unapproved and improperly labeled drug products that were marketed, sold and distributed via the Internet by Flawless Beauty LLC, of Asbury Park, New Jersey, have been seized by U.S. Marshals at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of New Jersey. These products, including injectable drug products, were marketed, sold and distributed to individuals, retail outlets, health spas and clinics.
Tullia’s Recalls Sauce Because of Possible Health Risk
Tullia’s is recalling Italian Meatless Pasta Sauce code 530140. This recall has been initiated because a records review by the Washington State Department of Agriculture revealed that one batch of sauce produced with the 530140 code had a pH level high enough to allow the growth of Clostridium botulinum. If present, this organism can cause botulism, a serious and potentially fatal foodborne illness.
FDA approves Keytruda for advanced melanoma
The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.
La Orocovena Biscuit Voluntarily Recalls Pound Cake de Queso Due to Undeclared Milk, Soy and Wheat
Through this means we inform to all La Orocoveña Biscuit clients that we will be conducting a recall of the product Pound Cake de Queso, 2oz. Exp. Dates 08/11/2014 to 10/12/2014, this since the product contains undeclared milk, wheat and soy.
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Tjs Place recalls Basil Pesto Pasta because of potential health risk
Tjs Place of Kirkland Washington is voluntarily recalling approx. 20 containers of Basil Pesto Pasta packed in 8 oz plastic tubs because it has 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.
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Martin Avenue Pharmacy, Inc. Issues a Voluntary Multi-State Recall of All Compounded Sterile Preparations Due to a Lack of Assurance of Sterility
Naperville, Illinois, Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
PEDIGREE Adult Complete Nutrition Limited Recall Due to Metal Fragments (Expanded)
At PEDIGREE, we care about all dogs and their safety and well-being is extremely important to us, and to our mission – to make a Better World for Pets. For that reason, we have announced the extension of a previous voluntary recall of PEDIGREE Adult Complete Nutrition dry dog food products due to the possible presence of a foreign material.
4C Foods Corp. Voluntarily Recalls 4C Grated Cheese Homestyle Parmesan Because of Salmonella Contamination
4C Foods Corp. is recalling its 6-oz. glass jars of “4C Grated Cheese HomeStyle Parmesan”, UPC 0-41387-32790-8 with code dates BEST BY JUL 21 2016 and JUL 22 2016 due to possible contamination with Salmonella. This recall does not impact any other 4C cheese products. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, elderly people, and others with weakened immune systems.
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Regeneca Worldwide, a Division of Vivaceuticals, Inc Expands the Voluntarily Recall of Regeneslim Appetite Control Capsules Due to the Presence of DMAA that May Pose Possible Health Risk
Regeneca Worldwide a division of VivaCeuticals, Inc. Las Vegas, NV is expanding the voluntary nationwide recall of its RegeneSlim appetite control dietary supplement to include lot #823230415, lot #EX0616r 15813, Lot # EX0616R15814 and Lot #11414re5516 because FDA analysis confirmed the presence of DMAA. DMAA is also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract. DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products.
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