November 5, 2014
Oasis Brands, Inc. de Miami, FL está retirando lotes selectos de productos Lácteos Santa Martha con fechas de vencimiento de 07/01/14 al 12/31/14, debido a que los productos tienen el potencial de estar contaminados con Listeria monocytogenes, un organismo que puede causar infecciones serias y a veces fatales en jóvenes, niños, personas débiles o ancianas, […]
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November 3, 2014
Taylor Farms New Jersey, Inc. of Swedesboro, NJ is voluntarily recalling 1,510 units of WAWA Garden Rotini Salad due to the potential of undeclared fish, wheat and egg allergens contained in the salad. Read The Complete Story!
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October 29, 2014
The U.S. Food and Drug Administration announced today the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
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October 24, 2014
Lundberg Family Farms announced that it is voluntarily recalling from distribution in the United States and Canada, specific bags of Sea Salt Rice Chips due to possible presence of an undeclared dairy allergen. The issue was discovered through a consumer complaint. Read The Complete Story!
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October 24, 2014
The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
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October 17, 2014
JFC International Inc. of Los Angeles, CA is voluntarily recalling all lot codes of its 3-pack Hapi Pudding with a net weight of 8.46 ounces (UPC 11152 13417), because they may contain undeclared milk. People who have allergies to milk run the risk of a serious or life-threatening allergic reaction if they consume the products. […]
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October 17, 2014
The U.S. Food and Drug Administration today approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
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October 15, 2014
The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).
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October 15, 2014
The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).
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October 15, 2014
The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).
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October 15, 2014
The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).
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October 14, 2014
A federal judge from the U.S. District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories, LLC, of Montvale, New Jersey on Oct. 10. The U.S. Department of Justice filed the consent decree on behalf of the U.S. Food and Drug Administration.
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October 14, 2014
A federal judge from the U.S. District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories, LLC, of Montvale, New Jersey on Oct. 10. The U.S. Department of Justice filed the consent decree on behalf of the U.S. Food and Drug Administration.
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October 14, 2014
The U.S. Food and Drug Administration today allowed marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder (impaired detrusor contractility or IDC).
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October 10, 2014
The U.S. Food and Drug Administration today approved Lumason (sulfur hexafluoride lipid microsphere) for patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves.
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October 10, 2014
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.
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October 10, 2014
The U.S. Food and Drug Administration today approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). This is the first drug-coated balloon used to re-open arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of peripheral artery disease (PAD).
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October 10, 2014
The U.S. Food and Drug Administration today approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy.
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October 9, 2014
LOTTE Confectionery Co., Ltd. (manufacturer), 21-5ka, Yangpyung-dong, Youngdeunpo-gu, Seoul, Korea, is recalling its 1.41 ounce (40g) and 5.64 ounce (160g) packages of Lotte Waffles because they contain undeclared egg ingredients. Read The Complete Story!
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