The U.S. Food and Drug Administration today approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding.
FDA orders recall under consent decree for all Custom Ultrasonics automated endoscope reprocessors
The U.S. Food and Drug Administration today ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm’s continued violations of federal law and a Consent Decree entered with the company in 2007. The identified violations could result in an increased risk of infection transmission. FDA ordered this recall under the terms of the Consent Decree. The agency also issued a safety communication today recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.
Giant Eagle Voluntarily Recalls Apricot Logs and Poppyseed Logs Due to an Undeclared Milk Allergen
All lots of Market District brand Apricot Logs and Poppyseed Logs prepared and sold individually from the Bakery department inside Giant Eagle and Market District supermarkets with sell by dates from November 7, 2015 through November 17, 2015 have been voluntarily recalled by Giant Eagle due to an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
FDA approves new pill to treat certain patients with non-small cell lung cancer
Today, the U.S. Food and Drug Administration granted accelerated approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). Tagrisso (osimertinib) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.
FDA releases groundbreaking food safety rules for produce farms and imported food to modernize and strengthen food safety system
The U.S. Food and Drug Administration today took major steps to prevent foodborne illness by finalizing rules implementing the bipartisan Food Safety Modernization Act that, for the first time, establish enforceable safety standards for produce farms, and make importers accountable for verifying that imported food meets U.S. safety standards. The Agency also issued a rule establishing a certification program for accredited entities conducting food safety audits of foreign food facilities. These final rules will help produce farmers and food importers take steps to prevent problems before they occur.
SpaghettiOs Original 14.2oz Cans Recalled Due to Potential Choking Hazard
Campbell Soup Company (NYSE:CPB) is voluntarily recalling 14.2 ounce cans of SpaghettiOs Original due to a potential choking hazard posed by pieces of red plastic found in a small number of cans. This plastic material is from parts of the can lining which may peel off.
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Homestat Farm Recalls Organic Steel Cut Oats & Chia With Flax And Rye Flakes Because Of Possible Health Risk
Homestat Farm of Dublin, OH is recalling some of its 42-ounce packages only of Organic Steel Cut Oats & Chia with Flax and Rye Flakes because the flax seed ingredient has 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 systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Trader Joe’s Issues Voluntary Allergy Alert on Tree Nuts In Trader Giotto’s Butternut Squash Triangoli
Trader Joe’s of Monrovia, California is voluntarily recalling Trader Giotto’s Butternut Squash Triangoli (UPC 00943482/SKU 94348) sold in the refrigerated deli section with “Use or Freeze by” codes 04 16 15 through 01 15 16, because it may contain undeclared tree nuts. All affected product has been removed from store shelves. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.
Halo, Purely for Pets® Issues Voluntary Recall of Sensitive Cat Turkey Dry Food Due to Mold
Halo, Purely for Pets has initiated a limited, voluntary recall of its Spot’s Stew Sensitive Cat Turkey kibble with a Best By date of 09/04/2016 due to reports of mold. No other Halo products are affected. Consumers who have Spot’s Stew Sensitive Cat Turkey stamped “Best By 09/04/2016” should discontinue feeding, and return the remaining portion to any Halo retailer for a full refund or replacement.
Old Oregon Smokehouse is Issuing a Voluntary Recall Canned Albacore Tuna Because of a Possible Health Risk
Old Oregon Smokehouse of Rockaway, Oregon is voluntarily recalling ALL canned Albacore tuna with any codes starting with “OC” because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.