Search Results for: labeling

BYETTA Kidney Failure Risk

November 5, 2009 By E. Sizemore 3 Comments

The FDA has announced labeling changes on the diabetes drug BYETTA (exenatide). The revisions will warn doctors and patients of the risk of kidney failure and renal insufficiency when taking the medication. So far there have been at least four reported deaths from kidney failure associated with BYETTA use. This is not the first significant health … [Read more...]

TRANS TECH ( 09V416000 )

November 1, 2009 By US Recall News Leave a Comment

Vehicle Make / Model: Model Year(s): TRANS TECH / MFSAB 2007-2009 Manufacturer: TRANS TECH BUS Mfr's Report Date: OCT 22, 2009 NHTSA CAMPAIGN ID Number: 09V416000 N/A NHTSA Action Number: N/A Component: EQUIPMENT:OTHER:LABELS Potential Number of Units … [Read more...]

FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency

October 2, 2009 By The FDA 1 Comment

The U.S. Food and Drug Administration (FDA) is alerting healthcare providers of a change to the United States Pharmacopeia (USP) monograph for heparin, effective October 1, 2009. Manufacturers will not begin shipping heparin products manufactured and tested according to the new USP monograph until October 8th or later. This change—largely in … [Read more...]

Price Rite 25 Ct Beef Bouillon Recalled: Allergy Alert

September 25, 2009 By The FDA Leave a Comment

Sept 24, 2009 - associated Brands Inc. of Medina, New York is voluntarily recalling 320 cases (3,840 selling units) of "Price Rite Beef Flavored Bouillon Cubes", lot code 22 JUL 11, as the lot has the potential to contain a dairy allergen which is not declared on the label. Consumers who have an allergy to milk may run the risk of a serious or … [Read more...]

Portex Uncuffed Pediatric-Sized Tracheal Tubes

September 22, 2009 By The FDA Leave a Comment

Smiths Medical announced that it is initiating a nationwide voluntary recall of Portex® Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) manufactured before September 2009. Description of the Issue A small number of tubes were manufactured with internal diameters slightly smaller than indicated on the labeling, which may create … [Read more...]