Evershing International Trading Company is recalling 16 ounces Coconut Tree Brand Frozen Shredded Coconut because they have the potential to 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 system. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting in to the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. No illnesses have been reported to date.
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Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial
AuroMedics Pharma LLC is voluntarily recalling lot AFO l 17001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product has been found to contain glass particles.
California Popsicle, Inc. Issues Allergy Alert on Undeclared Milk in Ice Bars
California Popsicle, Inc. dba Polly Ann Ice Cream of South San Francisco, CA is recalling ice bars, because it may contain 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 these products.
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Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. FDA is releasing two documents that together will improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications, or ANDAs).
T. Marzetti Company Voluntarily Recalls Frozen Biscuit Dough Packed Under Various Brands Due to Potential Listeria Contamination
As a precautionary measure, T. Marzetti Company is voluntarily recalling all “Best By” dates of the following products that were distributed in Alabama, Florida, Georgia, Indiana, Kentucky, Louisiana, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia, because they may 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.
PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products due to Lack of Sterility Assurance
December 27, 2017 Lake Forest, IL PharMEDium Services, LLC (PharMEDium) is voluntarily recalling the below lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, PharMEDium has not received any reports of complaints related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility.
New Seasons Market Issues Allergy Alert on Undeclared Egg in Packaged Macaroni and Cheese
New Seasons Market has initiated a voluntary recall of its New Seasons Market Grab and Go pre-packaged Macaroni and Cheese because it may contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of an allergic reaction if they consume this product.
Daisy’s Bakery Inc. Issues Alert On Undeclared Milk In “Gourmet Concha”
Daisy’s Bakery Inc. of Clifton, New Jersey is recalling 4 ounce packages of Gourmet Concha, because it may contain 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 these products.
FDA permits marketing of device to treat diabetic foot ulcers
FDA permits marketing of device to treat diabetic foot ulcers
Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Linezolid Injection 600mg/300ml, due to Presence White Particulate Matter that has been Identified as Mold
AuroMedics Pharma LLC is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter that has been identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag from one batch CLZ160007 was found to contain white particulate matter.