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.
Statement from FDA Commissioner Scott Gottlieb, M.D. on efforts to support more efficient and effective food recalls
FDA discusses the steps taken to improve the recall process, the HHS OIG report on recalls, and new policies being considered.
Nodine’s Smokehouse Inc. is Recalling Smoked Salmon 1.5 lbs, 8 oz Packages Due to Possible Listeria Monocytogenes Contamination
Nodine’s Smokehouse, Inc. of Torrington, Connecticut is recalling Smoked Salmon 1.5 lbs, 8 oz packages. Lot numbers 40173 and 33173 because they have the potential to be contaminated with Listeria monocytogenes. Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, with high fever, severe headache, neck stiffness, and nausea as its primary symptoms. In rare cases, listeriosis is fatal; it can also cause miscarriages and stillbirths. People experiencing these problems should seek immediate medical attention. Pregnant women the very young, elderly, and persons with compromised immune systems are
the most susceptible.
Voluntary Recall on Harris Teeter’s HT Traders Mama Biscotti Mini Biscotti – Triple Chocolate
Harris Teeter is notifying 153 shoppers who purchased HT Traders Mama Biscotti Mini Biscotti – Triple Chocolate since Dec. 8, 2017. The company’s supplier, Mom’s Best Gourmet Foods, Inc., is issuing a voluntary recall due to potential undeclared almonds and hazelnuts. The company has notified the shoppers for which it has customer data via telephone and email; the company hopes this statement will reach any shoppers for which the company does not have customer data.
Fresh Pak Inc. Recalls Lot Specific Sliced Apple Products Because of Possible Health Risk
Fresh Pak Inc. of Detroit, MI is announcing a voluntary Lot specific recall of red/green apple slices. Jack Brown Produce, Inc. (supplier) requested Fresh Pak Inc. to perform a recall for the reason that they could have potentially been contaminated with Listeria monocytogenes, an organism that 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.
Read The Complete Story!
FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response
FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response