The U.S. Food and Drug Administration today announced it has awarded 15 grants totaling more than $14 million to boost the development of products for patients with rare diseases.
Category Archives: Food Safety News
FDA takes enforcement action against Oregon dietary supplement manufacturer
The U.S. Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, is seeking a permanent injunction against the dietary supplement manufacturer James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.
FDA approves Opsumit to treat pulmonary arterial hypertension
The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transplantation.
Yoder’s Country Market, Inc. Issues Allergy Alert on Gift Boxes Containing 11 oz. Bags of Honey Roasted Peanuts Distributed in December 2012
Yoder’s Country Market, is recalling custom gift boxes distributed in December 2012 because they may contain 11 oz. bags of honey roasted peanuts which contain undeclared milk and wheat. People who have allergies to milk or wheat run the risk of serious or life-threatening allergic reaction if they consume the honey roasted peanuts. No other components of the gift boxes are affected.
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FDA approves new pediatric use for Liposorber Apheresis System
The U.S. Food and Drug Administration today approved Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before transplant, or after renal (kidney) transplantation in which there is recurrence of FSGS.
FDA approves Adempas to treat pulmonary hypertension
The U.S. Food and Drug Administration today approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension.
D.F. Stauffer Biscuit Co., Inc. Issues Allergy Alert and Voluntary Recall on 44 oz. Market Pantry White Fudge Coated Animal Cookies Due to Mislabeling and Undeclared Allergens
D. F. Stauffer Biscuit Co., Inc. is voluntarily recalling several lots of 44 oz. Market Pantry White Fudge Coated Animal Cookies because they may contain undeclared milk and eggs.
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Orange County Produce, LLC Recalls Bell Peppers Due to Possible Health Risk
Orange County Produce, LLC (“OC Produce”) is voluntarily working with the Food and Drug Administration (“FDA”) and California Department of Public Health (“CDPH”) to coordinate a recall of fresh red and green Bell Peppers for potential contamination with Salmonella. The FDA has advised that a random sample of OC Produce Bell peppers has tested positive for Salmonella.
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FDA approves Clinolipid for intravenous nutrition
The U.S. Food and Drug Administration today approved Clinolipid (lipid injectable emulsion, USP) for intravenous feeding (parenteral nutrition) in adult patients, providing a source of calories and essential fatty acids for adult patients who are unable to eat or drink.
Mandy Star Trading Inc. Is Issuing an Alert on Undeclared Sulfites in "Good Taste" Brand Plum
Mandy Star Trading Inc., located at 349 Maujer Street Brooklyn NY 11206 is recalling “Good Taste” brand Plum, because it contains undeclared sulfites and unallowed E124 (Acid Red 18) dye. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening allergic-like reactions if they consume this product.
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