Recall Class: Class I Date Recall Initiated: September 2, 2010 Product: Disposable Syringe with Normal Saline (0.9% Sodium Chloride, 5mL fill in 6mL syringe) This recall pertains ONLY to the 5mL fill in 6mL prefilled saline flush syringe with Normal Saline (0.9% Sodium Chloride), with the following product code numbers: E0100-50 10056-1000 10056-240 14056-240 910056-1000…
Safety Investigation of Non-Coring (Huber) Needles: Updated October 26, 2010
Original Date Issued: January 26, 2010 Date updated: October 25, 2010 Audience: Healthcare Practitioners and Patients/Caregivers Medical Specialties: Multiple, including Interventional Radiologists, Oncologists, Infusion Nurses Device Summary of Problem and Scope FDA Activities Recalls UPDATED October 25, 2010 All-Med Medical Products, Inc. and Marquette Medical, Inc. Huber Needles and Administration Sets Containing Huber needles Distributed from…
FDA Drug Safety Communication: Invirase (saquinavir) labels now contain updated risk information on abnormal heart rhythms
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary Safety Announcement [10-21-2010] The U.S. Food and Drug Administration is notifying the public that new risk information has been added to the label of the antiviral drug Invirase (saquinavir), describing a potential change in the electrical activity of the heart when Invirase is used with…
Class I Medical Device Recall: CareFusion Corporation, Alaris PC Units (Model 8015)
Recall Class: Class I Date Recall Initiated: July 13, 2010 Product: Alaris PC unit (model 8015) The Alaris PC Unit Model 8000 is NOT affected by this recall. The affected serial numbers are found on the company’s website. See below under Useful Links. These devices were manufactured from December 20, 2008 through September 8, 2009…
Warning Letters 2010
2010 Warning Letters and Untitled Letters to Pharmaceutical Companies      These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office. This page only covers Division of Drug Marketing and Communications and Headquarters Warning Letters. For District Office Warning Letters see the Main FDA FOI Warning Letters Page.  Some of the letters have…
FDA Drug Safety Communication: Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary Safety Announcement [10-13-2010] The U.S. Food and Drug Administration (FDA) is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information will be…
Questions and Answers on Unapproved Chelation Products
The U.S. Food and Drug Administration (FDA) advises consumers to be wary of so-called “chelation†products that are marketed over-the-counter (OTC) to prevent or treat diseases. Companies are marketing unapproved OTC chelation therapy products to patients with serious and incurable diseases, including autism spectrum disorders and heart (cardiovascular) conditions. 1. What is chelation? Chelation involves…
Class I Medical Device Recall: Multi-Med, Inc. Huber (Non-coring) Needles and Finished Devices Containing Huber Needles Labeled as 'All-Med Medical Products, Inc.' and 'Marquette Medical, Inc.' Brands and Provided to Some Consignees in Bulk Without Labeling
Huber needles are safety needles used on vascular access ports implanted in patients in need of repeated intravenous therapy. A “coring” Huber needle could damage the implanted port by removing silicone slivers from the access membrane. The defect in the port as a result of coring can cause the ports to leak. The core can…
Class I Medical Device Recall: Westmed Inc., BagEasy Manual Resuscitation Devices
Recall Class: Class I Date Recall Initiated: June 22, 2010 Products: BagEasy Manual Resuscitation Devices To find all the part and lot numbers and the specific descriptions of the devices affected by this recall, see the Firm Press Release under Useful Links below. Use: This type of manual emergency resuscitator provides emergency respiratory support using…
Bisphosphonates (Osteoporosis Drugs): Label Change
including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast  [Posted 10/13/2010] AUDIENCE: Patient, Family Practice, Geriatric ISSUE: FDA is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information…