FDA Medical Watch Alerts

List of FDA Medical Watch Alerts

Showing 10 of 42 records (Sample Data)

Date Reported Drug Name Status
07/09/2015 Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken.
07/02/2015 Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall - Intake Port Blockage Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death.
07/01/2015 Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality Unapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.
07/01/2015 Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects FDA investigating the safety of codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for slowed or difficult breathing.
07/01/2015 FLOW-i Anesthesia Systems by Maquet: Class I Recall - Dislodged Patient Cassette May Stop Patient Ventilation May cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.
06/24/2015 Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes by Medtronic: Recall - Tubes Formed With Wider-angle Bend Than Standard Models Reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients.
06/24/2015 Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes New warning added to drug label to describe risk of chemical leukoderma. chemical leukoderma, have been associated with the use of the Daytrana patch.
06/24/2015 Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes New warning added to drug label to describe risk of chemical leukoderma. chemical leukoderma, have been associated with the use of the Daytrana patch.
06/24/2015 Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes by Medtronic: Recall - Tubes Formed With Wider-angle Bend Than Standard Models Reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients.
06/22/2015 HeartWare Ventricular Assist System: Class I Recall – Updated with Multiple Reasons for Recall FDA will update recall with new information as it becomes available.

Notes

  • Last updated on June 27, 2015