Search Results for: labeling

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...]

FDA Requires Boxed Warning for Promethazine Hydrochloride Injection

September 17, 2009 By The FDA Leave a Comment

The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA’s authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting … [Read more...]

AFC Trading & Wholesale Recalls AFC Beancurd Sheets and Sticks

September 16, 2009 By The FDA Leave a Comment

AFC Trading & Wholesale, Inc., of Los Angeles, CA, recalls AFC Frozen Beancurd Sheets (8oz. & 16oz.) and AFC Frozen Beancurd Sticks (8oz.) because of it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products. No illnesses … [Read more...]

Smiths Medical Issues Urgent Device Recall Of Portex Pediatric-Sized Tracheal Tubes

September 12, 2009 By The FDA Leave a Comment

Jaguar Recalls 34 Year 2010 XF Vehicles

August 9, 2009 By US Recall News Leave a Comment

Vehicle Make / Model: Model Year(s): JAGUAR / XF 2010 Manufacturer: JAGUAR LAND ROVER NORTH AMERICA, LLC Mfr's Report Date: JUL 29, 2009 NHTSA CAMPAIGN ID Number: 09V316000 N/A NHTSA Action Number: N/A Component: EQUIPMENT:OTHER:LABELS Potential Number of … [Read more...]