Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance
If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. (Source: FDA MedWatch)
Source: FDA MedWatch - July 25, 2015 Category: American Health Source Type: news
0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter
Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs. (Source: FDA MedWatch)
Source: FDA MedWatch - July 20, 2015 Category: American Health Source Type: news
Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns
Monitor patients, especially those with risk factors for pulmonary hypertension, for signs of respiratory distress, including tachypnea, flaring nostrils, grunting, and chest wall retractions. (Source: FDA MedWatch)
Source: FDA MedWatch - July 16, 2015 Category: American Health Source Type: news
Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration
(Source: FDA MedWatch)
Source: FDA MedWatch - July 14, 2015 Category: American Health Source Type: news
Lariat Suture Delivery Device for Left Atrial Appendage (LAA) Closure by SentreHEART: FDA Safety Communication - Reports of Patient Deaths and Other Serious Adverse Events
Safety and effectiveness of the Lariat Suture Delivery Device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established. (Source: FDA MedWatch)
Source: FDA MedWatch - July 13, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - July 9, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - July 2, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - July 1, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - July 1, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - July 1, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - June 24, 2015 Category: American Health Source Type: news
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. (Source: FDA MedWatch)
Source: FDA MedWatch - June 24, 2015 Category: American Health Source Type: news
HeartWare Ventricular Assist System: Class I Recall – Updated with Multiple Reasons for Recall
FDA will update recall with new information as it becomes available. (Source: FDA MedWatch)
Source: FDA MedWatch - June 22, 2015 Category: American Health Source Type: news
M/L Taper with Kinectiv Technology Prosthesis by Zimmer: Class I Recall - Higher than Expected Levels of Manufacturing Residues
Can cause serious adverse health issues including allergic reactions, pain, infections, or death. (Source: FDA MedWatch)
Source: FDA MedWatch - June 20, 2015 Category: American Health Source Type: news
HeartWare Ventricular Assist System: Class I Recall - Damaged Alignment Guides or Connection Pins May Cause Pump to Stop
An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death. (Source: FDA MedWatch)
Source: FDA MedWatch - June 16, 2015 Category: American Health Source Type: news
