Recalls, Market Withdrawals, and Safety Alerts Important to GI – Archives


October 26, 2012
Class Recall: Ethicon Endo-Surgery Circular Stapler Sets – User Difficulty With Firing Stapler Devices

FDA announced a recall on October 26, 2012 for these products distributed from April 2011 to July 2012. According to the agency, users have had difficulty using the stapler device in procedures to treat prolapse or hemorrhoids.

August 14, 2012
Hospira announces a nationwide recall of three lots of Propofol Injectable Emulsion, 1%, 1g/100 mL

On August 14, 2012 Hospira announced a nationwide recall of three lots of Propofol due to visible particles embedded in the glass to the user level. There may be potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.

February 9, 2012
FDA MedWatch – Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs

Drug Safety Communication – Hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together

February 8, 2012
FDA Drug Safety Communication: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)