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.
HeartSine Technologies, Ltd. Issues Global Correction Of Samaritan® 300/300P PAD
On September 13, 2012, HeartSine Technologies, Ltd. initiated a voluntary global correction of certain Samaritan® 300/300P PAD public access defibrillators to address two separate issues that may affect the ability to deliver therapy to a patient in a sudden cardiac arrest (SCA) event, if needed. Certain Samaritan® 300/300P PAD devices manufactured before December 2010 have been found to intermittently turn on and off, which may eventually deplete the battery.
Wildwood Seed & Specialties Voluntarily Recalls Pet Bird And Small Pet Animal Food Due To Possible Salmonella Contamination
Wildwood Seed & Specialties, Monroe, Oregon, is voluntarily recalling a limited supply of their Sleek and Sassy brand bird and small animal foods that contain raw in-shell peanuts. These products contain peanut ingredients recalled by Sunland Inc. due to their potential to be contaminated with Salmonella.