Ladyfingers Caterers is voluntarily recalling its Signature Shaved Country Ham Rolls as a result of the Johnston County Hams recall. The rolls were made with ham produced by Johnston County Hams, which recently initiated a recall of its ham products due to possible contamination with Listeria monocytogenes. Listeria monocytogenes 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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FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled
Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm’s pasteurized cow’s milk cheeses, “Margie,” made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY.
The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade “A” Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to “Margie” cheese with a Made Date of 8/28/2018 and Best By date of 11/12/2018. To date, no illnesses have been reported to the Department in connection with this product.
FDA allows marketing of first self-fitting hearing aid controlled by the user
FDA allows marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables the user to fit, program and control the hearing aid on his or her own, without assistance from a health care provider.
Callie’s Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams
Johnston County Hams, Inc. issued a voluntary recall on October 3, 2018 for approximately 89,096 pounds of ready-to-eat ham products due to possible contamination with Listeria monocytogenes. In response, Callie’s Charleston Biscuits, LLC is issuing a voluntary product recall for two products that may contain the potentially affected Johnston County Hams.
Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk
Working Cow Homemade Ice Cream, Inc. of St. Petersburg, FL is conducting a voluntary recall of No Sugar Added Vanilla and No Sugar Added Chocolate ice cream manufactured in three-gallon tubs during the month of May 2018. The recall is being conducted due to a potential contamination 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 monocytogenes infection can cause miscarriages and stillbirths among pregnant women.
Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination
Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions
FDA issues revised guidance to allow for a more efficient approach to 505(q) petitions and focus more resources on scientific reviews.
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients
FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients
FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation
The FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur development of drugs targeting serious infections in limited patient populations with unmet need.