FDA News

Latest News from U.S.FDA

FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus

The U.S. Food and Drug Administration today published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA).

FDA Transparency Task Force to Hold 2nd Public Meeting on Ensuring That Agency Information is Useful, Understandable, Accessible

The U.S. Food and Drug Administration will seek comments on three specific issues related to transparency at the agency during a daylong public meeting on Tuesday, Nov. 3, 2009.

Byetta (exenatide) - Renal Failure

Cases of altered kidney function, including acute renal failure and renal insufficiency, in patients using Byetta.

FDA: Byetta Label Revised to Include Safety Information on Possible Kidney Problems

The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes.

Allergy Alert on Possible Undeclared Soy Protein in32-ounce Great Value Half & Half, 32-ounce Great Value 36% Heavy Whipping Cream, 32-ounce Kroger brand 36% Heavy Whipping Cream, and 64-ounce Wholesome Farms Chocolate Ice Cream Mix

Morningstar Foods is voluntarily recalling 32-ounce Great Value Half & Half, UPC 6 05388 187 16 1, item code 1871600, plant code 21-031; 32-ounce Great Value 36% Heavy Whipping Cream, UPC 6 05388 187 18 5, item code 1871800, plant code 21-031; 32-ounce Kroger brand 36% Heavy Whipping Cream, UPC 0 11110 438 28 7, item code 4382900, plant code 21-031; and 64-ounce Wholesome Farms Chocolate Ice Cr

Alexia Foods issues nationwide allergy alert and product recall on its Alexia Olive Oil, Sun-Dried Tomatoes & Pesto Oven Reds frozen potatoes due to undeclared pine nut allergen

Today, Alexia Foods, Inc, Kennewick, WA, in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling packages of its Alexia – Olive Oil, Sun-Dried Tomatoes & Pesto Oven Reds (frozen seasoned potato wedges) for an undeclared allergen, pine nuts.

Pointe Scientific, Inc Expands Nationwide Recall of Liquid Glucose Hexokinase Reagent (G7517)

Pointe Scientific, Inc, Canton, MI is initiating a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range.

Pointe Scientific Liquid Glucose Hexokinase Reagent - Recall

Nationwide recall of all size kits. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range.

Cordis Initiates Nationwide Recall of CROSSOVER™ Sheath Introducer

Cordis Corporation announced today a nationwide voluntary recall of all lots of the CROSSOVER™ Sheath Introducer due to complaints about stretching or fracture of the sheath during use.

The CROSSOVER™ Sheath Introducer is a product developed and manufactured by Thomas Medical Products, Inc., and distributed by Cordis.

Pointe Scientific, Inc Issues Nationwide Recall of Liquid Glucose Hexokinase Reagent (G7517)

Pointe Scientific, Inc, Canton, MI is initiating a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range.

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