Today the U.S. Food and Drug Administration proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more broadly.
FDA orders postmarket surveillance of certain TMJ implants
TMJ, postmarket, surveillance
Qualitest Pharmaceuticals Issues Voluntary, Nationwide Recall Of Hydrocodone Bitartrate And Acetaminophen Tablets, USP 10 MG / 500 MG, NDC 0603-3888-20, 60 Count, Lot Numbers T150G10B, T120J10E And T023M10A And Phenobarbital Tablets, USP 32.4 MG, NDC 0603-5166-32, 1000 Count, Lot Numbers T150G10B, T120J10E And T023M10A
Qualitest Pharmaceuticals today issued a voluntary nationwide recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A, and Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A. An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Lots T120J10E and T023M10A used the same stock inventory of labels as Lot T150G10B and are potentially impacted.
Rouses Markets Voluntarily Recalls Frozen Yellow Fin Tuna Steaks Due To Possible Health Risks
Rouses Markets (www.rouses.com) announced the voluntary recall of wild-caught yellow fin tuna steaks labeled as product of USA with a UPC Code beginning with 208732 sold at Rouses Markets with Sell By dates between December 1, 2010 and January 27, 2011. These previously frozen tuna steaks are being recalled because of potential elevated levels of histamine.
FDA clears first diagnostic radiology application for mobile devices
iPhone, iPad, radiology
FDA approves drug to reduce risk of preterm birth in at-risk pregnant women
The U.S. Food and Drug Administration today approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.
Watson Announces Important Action Related to Nationwide Recall of Triad Alcohol Prep Products Included in Products
Watson Pharmaceuticals, Inc. (NYSE: WPI), announced today the market recall of alcohol prep pads manufactured by Triad Group which is a component of a convenience kit that is distributed with its products. Triad Group is recalling the alcohol prep pads packaged with products, including Watson’s Trelstar® (triptorelin pamoate for injectable suspension) product, due to potential contamination of the pads with the bacteria, Bacillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.
American Regent Initiates Nationwide Voluntary Recall of Potassium Phosphates Injection, USP 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium 5 mL Single Dose Vial, Lot# 0048 Due to Translucent Visible Particles
American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product: Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium 5 mL Single Dose Vial NDC # 0517-2305-25 Lot #0048 Exp Date: January, 2012 PLEASE NOTE: This recall, initiated on February 3, 2011 to the User or Consumer Level, is for lot # 0048 Only.
American Spoon Foods brand Apple Chipotle Salsa, Maple BBQ Grilling Sauce, and Pumpkin Chipotle Roasting Sauce may contain undeclared wheat flour and may put certain consumers at risk for wheat or gluten sensitivities or allergies.
American Spoon Foods is voluntarily recalling Apple Chipotle Salsa, Maple BBQ Grilling Sauce, and Pumpkin Chipotle Roasting Sauce. These three products may have various lot codes.
Shaping Beauty, Inc. Issues a Voluntary Nationwide Recall of Weight Loss Pills Found to Contain an Undeclared Drug Ingredient
Shaping Beauty, Inc. has been informed by the Food and Drug Administration (FDA) that a weight loss dietary supplement sold and marketed by the firm contain an undeclared drug ingredient. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared Sibutramine used as an appetite suppressant for weight loss.