Nidek Medical Products, Inc., today announced that the U.S. Food and Drug Administration (FDA) has classified Nidek’s voluntary recall action regarding capacitor-related fires in Medical Mark5 Nuvo Lite Oxygen concentrators as a Class I recall. The affected devices were manufactured and distributed from January 2004 through May 2010 with serial numbers in the range of 042-10000 through 102-09335.
Category Archives: Food & Drug Recalls
Hannaford Mini Frosted Cookies: Egg Ingredient Warning
Hannaford Supermarkets is notifying consumers today that Hannaford brand Mini Frosted Cookies contain egg as an ingredient. The Mini Frosted Cookies in 10-ounce packages (UPC # 4126872374) with labels that did not list egg as an ingredient have been removed from shelves at Hannaford stores.
Truitt Bros., Inc. Issues Allergy Alert On Undeclared Soy In 15 Oz Premium Navy Beans
Truitt Bros., Inc. of Salem, Oregon is voluntary recalling 15oz Premium Navy Beans, because it may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.
Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena)
Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena)
FDA urges that oysters, clams, mussels, and some types of scallops from Korea should be removed from the market
The U.S. Food and Drug Administration is urging food distributors, retailers, and food service operators to remove from sale or service all fresh, frozen, canned, and processed oysters, clams, mussels, and whole and roe-on scallops (molluscan shellfish) from Korea that have entered the United States. This includes molluscan shellfish from Korea that entered the United States prior to May 1, 2012, when the FDA removed such products from the Interstate Certified Shellfish Shippers List (ICSSL), and that which may have inadvertently entered the country after that date. These products and any products made with them may have been exposed to human fecal waste and are potentially contaminated with norovirus.
FDA approves new combination vaccine that protects children against two bacterial diseases
The U.S. Food and Drug Administration today approved Menhibrix, a combination vaccine for infants and children ages 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b.
Golden Glen Creamery Issues Voluntary Recall Of Red Pepper Onion & Garlic Cheddar Because Of Potential Health Risk
Golden Glen Creamery of Bow, WA, in cooperation with the WSDA is voluntarily recalling Red Pepper with Onion & Garlic Cheddar produced on August 30, 2011 because it has the potential to be contaminated with Listeria monocytogenes. The Creamery agreed to recall the product after a sample taken by the WSDA returned with a positive result.
Unilever Issues Allergy Alert On Pints Of Ben & Jerry’s Chocolate Nougat Crunch Ice Cream:Sweet Cream Ice Cream with Fudge Covered Wafer Cookies & a Chocolate Nougat Swirl
Unilever is voluntarily recalling pint containers of its Ben & Jerry’s Chocolate Nougat Crunch Ice Cream: Sweet Cream Ice Cream with Fudge Covered Wafer Cookies & a Chocolate Nougat Swirl (“Chocolate Nougat Crunch”) that are missing the allergen advisory statement, “Allergy Information: Fudge covered wafer pieces have been manufactured on shared equipment that processes peanuts and tree nuts.” This allergen advisory statement should be at the end of the ingredients list but was inadvertently omitted from the recalled product.
FDA approves Perjeta for type of late-stage breast cancer
The U.S. Food and Drug Administration today approved Perjeta (pertuzumab), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage (metastatic) breast cancer.
Best Maid Cookie Company Issues Allergy Alert On Undeclared Walnut In Product
Best Maid Cookie Company of River Falls, Wisconsin is recalling Sienna Bakery brand Oatmeal Walnut Raisin and Sienna Bakery brand White Chocolate Macadamia Nut cookies due to the potential of undeclared walnut allergen.