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Recalls 1502 articles

Baxter expands recall of intravenous heart drug

Baxter International is expanding a November 2017 recall of the heart drug Nexterone due to the presence of particle matter found floating in bags of the solution. If a patient receives an intravenous dose of a solution containing sterile particulate matter, he could experience adverse health reactions, the extent and severity of which depends on the size, number and composition of the foreign material and the patient’s underlying medical condition. “In the absence of in-line filtration,” the company said in a news release, “these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary ... Read More

PharMEDium expands recall of compounded drug products

PharMEDium Services LLC is expanding a Dec. 27, 2017, recall to include additional lots of sterile drug products due to the sterility concerns that could cause serious and potentially life-threatening infections to patients. A list of affected products can be found on the company’s website. The recall was expanded because PharMEDium conducted an extensive review of all commercially distributed product lots compounded in the Memphis, Tennessee, location currently within their labeled expiration date in response to a request by the Food and Drug Administration (FDA) regarding microbial program controls for the ISO5 environment, personnel glove sampling results, media fill results, ... Read More

Heart valve device recalled due to dangerous defect

Edwards LifeSciences is recalling a heart valve device due to a defect that could cause the device to break off inside the patient, which could obstruct blood flow to critical organs leading to severe neurologic, cardiac, limb, renal, or gastrointestinal injuries. The recall involves Edward LifeSciences’ Certitude Delivery System, used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), which is typically used during a transcatheter aortic valve replacement. The recall is being initiated due to a molding overflow defect in the button vale within the loader. The overflow material could detach during placement of the delivery system ... Read More

Blood thinner recalled over drug ingredient mixup

International Laboratories LLC is recalling one lot of the blood thinner Clopidogrel because the pills may contain the cholesterol-lowering statin Simvastatin instead. The recall affects Lot # 117099A of Clopidogrel Tabloets, USP 75mg, packaged in bottles of 30 tablets. The affected lot was delivered to distribution centers in Arkansas, Georgia, Indiana, California and Maryland, and then distributed to retail stores throughout the U.S. Patients prescribed Clopidogrel, the active drug ingredient in Plavix, who miss doses of this medication are at an increased risk of heart attack and stroke, both of which can be life threatening. Additionally, unintentional consumption of Simvastatin, ... Read More

Fieldbrook expands cream bar recall to include raspberry cream bars

The Fieldbrook Foods Corporation’s cream bar recall has expanded once again, to include more than 28,000 cases of Raspberry Cream Bars that were included with Orange Cream Bars in ALDI seasonal split-case purchases. The expanded recall adds to a previous recall of all orange cream bars and chocolate coated vanilla ice cream bars that were produced in 2017 on the company’s Hoyer 1 Line at its Dunkirk, New York plant. Bars manufactured at the other two Fieldbrook Foods plants are not affected. The recall was initiated because there is a risk the cream bars may be contaminated with Listeria monocytogenes, ... Read More

Cream bar recall expanded to include dozens more brands

Fieldbrook Foods Corporation is expanding a recall of select brands of orange cream bars to include all orange cream bars and chocolate coated vanilla cream bars that were produced in 2017 on the company’s Hoyer 1 Line at its Dunkirk, New York, plant. Both products are being recalled due to the possibility that they may be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and people with weakened immune systems. Healthy individuals may suffer short-term symptoms like high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. ... Read More

Orange cream bars recalled due to Listeria scare

Boxes of Tops brand Orange Cream Bars and Meijer Purple Cow brand Orange Cream Bars may look innocent enough with adorable animals posing next to the tasty treats. But buyer beware. Fieldbrook Foods Corporation, maker of the products, has issued a recall of 20 cases of the Tops brand product and 320 cases of Meijer Purple Cow brand cream bars because they may be contaminated with Listeria monocytogenes. The nasty organism can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. While healthy individuals may suffer only short-term symptoms such as ... Read More

Injectable antibiotic recalled

AuroMedics Pharma LLC is recalling one lot of an injectable antibiotic because glass particles were found floating in a single-dose vial. If glass is present in an intravenous drug and the drug is administered, it may cause local irritation or swelling. More serious complications that can occur include blockage and clotting in the blood vessels, which may be deadly. To date, AuroMedics Pharma has not received any reports of adverse effects related to this recall. The recall affects lot AFO l 17001-A, with the expiration date “Dec 2018” of Ampicillin and Sulbactam for injection USP, 1.5 g (equivalent to 1 ... Read More

PharmMEDium issues recall of several drug products

PharmMEDium Services LLC, is recalling several lots of drug products including injections of the opioids fentanyl, morphine and hydromorphine, because the sterility of the products cannot be ensured. Use of a drug intended to be sterile that is not sterile could cause serious infections that could be life threatening. The recall affects all products currently within their labeled expiration date. To date, PharmMEDium has not received any reports or complaints related to this issue. The recall comes following a Food and Drug Administration (FDA) inspection at the company’s Memphis laboratory, after which the agency requested verification of acceptable microbiological testing ... Read More

Heart catheter sheath recalled due to defect

Sterilmed Inc., is recalling the Sterilmed Reprocessed Agilis Steerable Indroducer Sheath, used with various cardiovascular catheters, due to a defect in the seal of the sheath that, if used, may lead to serious health complications, including death. The hemostatic valve is used to insert and position various cardiovascular catheters in the heart, including on the left side of the heart through the wall of tissue that separates the right and left chambers of the heart, called the interatrial septum. The device prevents blood from flowing back through the valve. The recall is being initiated because the device may fail due ... Read More