The U.S. Food and Drug Administration announced today that federal judge Algenon L. Marbley of the Southern District of Ohio has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group, LLC, of Lewis Center, Ohio, and four of its corporate officers and employees for continued drug manufacturing and labeling violations that resulted in the distribution of mislabeled drugs.
Category Archives: Food Safety News
FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert
The U.S. Food and Drug Administration today issued an import alert under which U.S. officials may detain at the U.S. border drug products manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The firm will remain on the import alert until the company complies with U.S. drug manufacturing requirements, known as current good manufacturing practices (CGMP).
FDA approves first generic capecitabine to treat colorectal and breast cancers
The U.S. Food and Drug Administration today approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer.
New medical device treats urinary symptoms related to enlarged prostate
The U.S. Food and Drug Administration today authorized the marketing of the UroLift system, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate.
FDA approves Botox Cosmetic to improve the appearance of crow’s feet lines
The U.S. Food and Drug Administration today approved a new use for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults. Botox Cosmetic is the only FDA approved drug treatment option for lateral canthal lines.
FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics
The U.S. Food and Drug Administration today announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.
General Mills Announces Voluntary Recall of Limited Quantity of Refrigerated Pillsbury Cinnamon Rolls With Icing
General Mills announced today a voluntary Class II recall of a limited quantity of refrigerated Pillsbury Cinnamon Rolls with Icing. No other flavors or varieties of Pillsbury Cinnamon Rolls or Pillsbury dough products are being recalled.
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Federal judge grants FDA request for consent decree with Idaho farm
The U.S. District Court for the District of Idaho entered a consent decree of permanent injunction against owner Gregory T. Troost, doing business as T&T Cattle and T&T Cattle Pearl, and manager Mark A. Mourton of Parma, Idaho for violations including illegally administering animal drugs for uses that are not approved by the U.S. Food and Drug Administration.
FDA approves Abraxane for late-stage pancreatic cancer
The U.S. Food and Drug Administration today expanded the approved use of Abraxane (paclitaxel protein-bound particles for injectable suspension) to treat patients with late-stage (metastatic) pancreatic cancer.
Cains Foods Issues an Allergen Alert for Undeclared Milk and Egg in Olde Cape Cod Chipotle Ranch Dressing
Cains Foods is recalling 2,273 six-pack cases of 16 oz. Olde Cape Cod Chipotle Ranch dressing with a “Best By” date of Nov. 30, 2014 because it may contain undeclared milk and egg. People who have allergies to milk and egg run the risk of serious or life-threatening reactions if they consume products containing these ingredients.
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