Archive for the ‘Food Safety News’ category

Oasis Brands, Inc. Retira Productos Lacteos Santa Martha debido a Posible de Riesgos a la Salud

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, […]

New Jersey Firm Issues Allergy Alert on Undeclared Fish, Wheat and Egg In Garden Rotini Salad

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!

First vaccine approved by FDA to prevent serogroup B Meningococcal disease

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.

Lundberg Family Farms Recalls Sea Salt Rice Chips Due to Undeclared Allergen

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!

FDA approves new treatment for rare form of hemophilia

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).

JFC International Inc. Issues Allergy Alert on Undeclared Milk in ‘Hapi Pudding’

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. […]

FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic

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.

FDA approves Ofev to treat idiopathic pulmonary fibrosis

October 15, 2014

The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

FDA approves Ofev to treat idiopathic pulmonary fibrosis

October 15, 2014

The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

FDA approves Esbriet to treat idiopathic pulmonary fibrosis

October 15, 2014

The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).

FDA approves Esbriet to treat idiopathic pulmonary fibrosis

October 15, 2014

The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).

Federal judge approves FDA consent decree with Ascend Laboratories

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.

Federal judge approves FDA consent decree with Ascend Laboratories

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.

FDA permits marketing of urinary prosthesis device for women

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).

FDA approves a new ultrasound imaging agent

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.

FDA approves first combination pill to treat hepatitis C

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.

FDA approves first drug-coated angioplasty balloon catheter to treat vascular disease

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).

FDA approves Akynzeo for nausea and vomiting associated with cancer chemotherapy

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.

Allergy Alert On Undelcared Eggs In Lotte Waffles

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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