Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary nationwide Class I recall of Symbiq™ infusion systems (list number 16026 Symbiq™ One-Channel Infuser and list number 16027 Symbiq™ Two-Channel Infuser, all serial numbers). This action is due to infusion pump LCD touch screens that may not respond to user selection, resulting in users possibly experiencing a delayed response and/or the screen registering a different value from the value selected by the user.
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BT McElrath Chocolatier, Inc. Announces Nationwide Recall Of Peanut Butter Pave Due To Possible Health Risks
: October 26th 2012 BT McElrath Chocolatier, Inc. is initiating a voluntary recall of the seasonal peanut butter pave because they have the potential to be contaminated with Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Schoep’s Ice Cream Company Issues Allergy Alert On Undeclared Allergen In Kays Classic Vanilla Bean Ice Cream
Schoep’s Ice Cream Company of Madison, Wisconsin is alerting customers that because of a packaging error, Kays Classic Vanilla Bean Ice Cream contains an undeclared allergen. Consumers, who have an allergy or severe sensitivity to pecans, run the risk of serious or life-threatening allergic reaction if they consume this product.
Premium Nutritional Products Announces Ongoing Voluntary Recall Of Select ZuPreem Bird Foods
On September 27, 2012, Premium Nutritional Products, Inc. initiated a voluntary recall of ZuPreem FruitBlend™ With Natural Fruit Flavors maintenance formula bird foods for medium/large birds and for large birds with use by date codes of 11/30/13 or 11/13 and lot numbers 598405052 or 598405072. The recall is being conducted due to the product containing the combination of exceedingly high calcium levels, low phosphorus, and high vitamin D concentration resulting in a significant health risk to the birds.
FDA reports conditions observed at New England Compounding Center facility
Today, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.
FDA approves Synribo for chronic myelogenous leukemia
The U.S. Food and Drug Administration today approved Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease.
Federal judge grants permanent injunction against Oregon herb and supplement manufacturer
A federal judge has granted the U.S. Food and Drug Administration a permanent injunction against Truman J. Berst, doing business as Alternative Health & Herbs Remedies of Albany, Ore., for selling products represented as herbs and supplements with claims for treating diseases.
FDA enters consent decree with New York dietary supplement manufacturer, Venus Pharmaceuticals
Venus Pharmaceuticals International Inc., of Hauppauge, N.Y., and Bharat Kakumanu, its chief executive officer, have agreed to stop production and distribution of dietary supplements into U.S. commerce and recall and destroy affected product produced prior to January 2012, due to repeated violations of current good manufacturing practice (cGMP) regulations. In addition, the firm is prohibited from exporting products unless such activity is in compliance with FDA laws and regulations.
Bumble Bar, Inc. Recalls Gluten Free Cafe™ Chocolate Sesame Bars and Gluten Free Cafe™ Cinnamon Sesame Bars Due to Possible Health Risk Associated With Sunland Inc. Peanut Products
Bumble Bar is recalling certain lots of Gluten Free Cafe™ Chocolate Sesame Bars and Gluten Free Cafe™ Cinnamon Sesame Bars associated with Sunland Inc. peanut products, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infection 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.
Tropical Valley Foods Issues Alert On Undeclared Allergens In Dark Chocolate, Organic Dark Chocolate, Milk Chocolate And Trail Mix Products Sold In Bulk
Tropical Valley Foods is alerting customers that because of a label error, Dark Chocolate, Organic Dark Chocolate and Trail Mix items which were sold in bulk quantities contain undeclared allergens. Consumers who have an allergy or severe sensitivity to wheat, soy or tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.