FluMist Quadrivalent, a vaccine to prevent seasonal influenza in people ages 2 years through 49 years, has been approved today by the U.S. Food and Drug Administration. FluMist Quadrivalent is the first influenza vaccine to contain four strains of the influenza virus, two influenza A strains and two influenza B strains.
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FDA reaches $1 million settlement with Pennsylvania medical device firm
The U.S. Food and Drug Administration has reached a $1 million civil money penalty settlement with Globus Medical Inc., of Audubon, Pa., for the distribution of unapproved medical devices.
FDA announces safety changes in labeling for some cholesterol-lowering drugs
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration (FDA).
These products, when used with diet and exercise, help to lower a person’s “bad” cholesterol (low-density lipoprotein cholesterol). The products include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).
Regeneca, Inc. Issues a Voluntary Nationwide Recall of All Lots of Single Capsule RegenErect Because of Potential Health Risks
Regeneca, Inc. (Pink Sheets:RGNA) announced today that it is conducting a voluntary nationwide recall of all lots of single capsule packet RegenErect, labeled as a dietary supplement.
Glenmark Generics Inc. Announces a Nationwide Recall of Seven (7) Lots of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (Generic) Due to Possibility of Out of Sequence Tablets
Glenmark Generics Inc. USA today issued a voluntary, nationwide, consumer-level recall of seven (7) lots of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.
FDA approves first Helicobacter pylori breath test for children
The first breath test for use in children ages 3 to 17 years to detect Helicobacter pylori (H. pylori) bacterial infections, responsible for chronic stomach inflammation (gastritis) and ulcers, was approved by the U.S. Food and Drug Administration (FDA) on Feb. 22, 2012.
Bedford Laboratoriesâ„¢ Issues Nationwide Voluntary Recall of Cytarabine for Injection, USP, 1 Gram per Vial
Bedford Lboratoriesâ„¢ annc=ounces a nationwidecoluntary recall for the following three lots of Cytarabine for Injection, USP. Cytarabine for injection, USP 1 gram per viral – NDC #55390-133-01.
Voluntary Recall Of Goya, Great Value, Hatuey, Mr. Special, Polar, Publix, Regal, And SuperMax Brand Malta Beverages In 7-oz Bottles Due To Possible Health Risk
The Florida Brewery, Inc. is recalling certain lots of Goya, Great Value, Hatuey, Mr. Special, Polar, Publix, Regal, and SuperMax brand non-alcoholic malta beverages packaged in 7-oz bottles because glass on the exterior of the bottles may break when the twist-off cap is removed from the bottle and can result in cuts to the mouth. To date, the Company has received two reports of consumers experiencing cuts to the mouth.
American Regent Initiates Nationwide Voluntary Recall Of Phenylephrine HCl Injection, USP, 1% 5 mL Vial, Lot# 0693 Due To Visible Particles
American Regent is conducting a nationwide voluntary recall to the Retail/Hospital level of the following product: Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vial NDC # 0517-0405-25, Lot # 0693, Exp Date: October, 2012. PLEASE NOTE: This recall, initiated on February 22, 2012 to the Retail/Hospital Level, is for Lot # 0693 only.
Federal government gains permanent injunction against raw milk producer
A federal court has granted the U.S. Food and Drug Administration a permanent injunction preventing Daniel L. Allgyer and his Rainbow Acres Farm from distributing raw milk and raw milk products in final package form for human consumption across state lines.