The U.S. Food and Drug Administration issued a draft guidance today describing its intent to exercise enforcement discretion with respect to the premarket notification requirements for certain in vitro diagnostic and radiology devices with well-established safety and effectiveness profiles.
FDA approves Xarelto to reduce risk of blood clots after hip, knee replacements
On July 1, the U.S. Food and Drug Administration approved Xarelto (rivaroxaban) to reduce the risk of blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE) following knee or hip replacement surgery.
FDA issues anti-smuggling strategy and draft guidance on new dietary ingredients
The U.S. Food and Drug Administration today announced that it has completed two tasks required by the new Food Safety Modernization Act (FSMA) and that new authorities to suspend the registration of food facilities and to administratively detain food that it has reason to believe are adulterated or misbranded have gone into effect.
Evergreen Fresh Sprouts, LLC Voluntarily Recalls Alfalfa Sprouts and Spicy Sprouts Because Of Possible Health Risk
Moyie Springs, Idaho-Evergreen Fresh Sprouts, LLC announced a voluntary recall of Alfalfa Sprouts and Spicy Sprouts because it has the potential to be contaminated with Salmonella. The recalled sprouts have been linked to a multistate outbreak of Salmonella infections.
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FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved Arcapta Neohaler (indacaterol inhalation powder) for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
FDA, Justice Department take action against California calf hauler
The U.S. Food and Drug Administration has announced that the United States District Court for the Eastern District of California, Sacramento Division, entered a consent decree of permanent injunction against John C. Virtue, doing business as Virtue Calves, and Shannon L. Virtue for selling veal calves for use as food that contain illegal drug residues in violation of federal law.
FDA: New York dietary supplement manufacturer enters into consent decree
The U.S. Food and Drug Administration has announced that Howard Sousa, doing business as the Artery Health Institute LLC, and DeSousa LLC, in New York, N.Y., has signed a consent decree of permanent injunction. The consent decree prohibits Sousa from distributing products with claims in the labeling to cure, treat, mitigate or prevent diseases.
McNeil Consumer Healthcare Announces Voluntary Recall Oe One Product Lot Of TYLENO® Extra Strength Caplets 225 Count Distributed In The U.S.
Fort Washington, PA – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling at the retail level one product lot (60,912 bottles) of TYLENOL®, Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recalled product was manufactured in February, 2009. McNeil is taking this action following a small number of odor reports, including musty, moldy odor. The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).
Risvold’s Salads Inc ISSUES ALLERGY ALERT ON UNDECLARED allergens in Seafood Salad and Seafood Pasta Salad
Risvold’s Salads Inc of Gardena, CA is recalling seafood salad and seafood pasta salad, because it may contain undeclared milk, sunflower, sesame and soy. People who have an allergy or severe sensitivity to milk, sunflower, sesame and soy run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA: Do not eat Evergreen Produce brand alfalfa sprouts or spicy sprouts
The FDA is advising consumers not to eat Evergreen Produce brand alfalfa sprouts and spicy sprouts. The sprouts are possibly linked to 20 reported cases, including one hospitalization, of Salmonella Enteritidis in Idaho, Montana, New Jersey, North Dakota and Washington State. The strain of S. Enteritidis is rarely seen at this frequency.