Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke
FDA requiring manufacturers to change labeling to clarify the approved uses of these medications, and to add information about a possible increased risk of heart attacks and strokes in patients taking testosterone. (Source: FDA MedWatch)
Source: FDA MedWatch - March 3, 2015 Category: American Health Source Type: news
HeartWare Ventricular Assist System Controllers by HeartWare International: Recall - Clinical Trial Controllers Susceptible to Electrostatic Discharge
Electrostatic discharge event could result in a pump stop, which could cause serious injury or death. (Source: FDA MedWatch)
Source: FDA MedWatch - February 27, 2015 Category: American Health Source Type: news
Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial by Heritage Pharmaceuticals: Recall - Lack of Sterility Assurance
Administration of non-sterile injection products may result in a site-specific or systemic infection, with the potential to cause hospitalization, permanent organ damage, or death. (Source: FDA MedWatch)
Source: FDA MedWatch - February 25, 2015 Category: American Health Source Type: news
Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit by GE Healthcare: Class I Recall - Potential Disabling of the Magnet Rundown Unit
Risk of life-threatening injuries or death if a metal object is brought into the magnetic field. (Source: FDA MedWatch)
Source: FDA MedWatch - February 25, 2015 Category: American Health Source Type: news
MAQUET Servo Humidifier 163 by Teleflex Medical: Class I Recall - Cracks in Connector Tubes May Lead to Leak Failures
Cracks may prevent device from delivering sufficient support to the patient. This may potentially cause serious injury or death. (Source: FDA MedWatch)
Source: FDA MedWatch - February 25, 2015 Category: American Health Source Type: news
Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall - Potential Impact on Product Sterility
Has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. (Source: FDA MedWatch)
Source: FDA MedWatch - February 24, 2015 Category: American Health Source Type: news
Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning
Patients may be exposed to serious infections. (Source: FDA MedWatch)
Source: FDA MedWatch - February 19, 2015 Category: American Health Source Type: news
Ketorolac Tromethamine Injection by Hospira: Recall - Particulate in Glass Vials
Administration of particulates has the potential for localized inflammation, allergic reaction, granuloma formation, microembolic effects, or delay of therapy. (Source: FDA MedWatch)
Source: FDA MedWatch - February 11, 2015 Category: American Health Source Type: news
Trellis 6 and Trellis 8 Peripheral Infusion Systems by Covidien: Class I Recall - Balloon Inflation Ports Mislabeled
The physician using the device may deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs. (Source: FDA MedWatch)
Source: FDA MedWatch - February 11, 2015 Category: American Health Source Type: news
0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate Matter
Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. (Source: FDA MedWatch)
Source: FDA MedWatch - January 23, 2015 Category: American Health Source Type: news
Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication - Reports of Serious Injuries
Risk of excess bone growth, fluid accumulation, inhibited bone healing, and swelling. (Source: FDA MedWatch)
Source: FDA MedWatch - January 21, 2015 Category: American Health Source Type: news
Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected
Adverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products. (Source: FDA MedWatch)
Source: FDA MedWatch - January 14, 2015 Category: American Health Source Type: news
Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy
Pregnant women urged to discuss all medicines with their health care professionals before using them. (Source: FDA MedWatch)
Source: FDA MedWatch - January 9, 2015 Category: American Health Source Type: news
Virazole (Ribavirin Powder For Solution) by Valeant Pharmaceutical North America, LLC: Recall- Due to Microbial Contamination
Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection. (Source: FDA MedWatch)
Source: FDA MedWatch - January 2, 2015 Category: American Health Source Type: news
KimVent Microcuff Subglottic Suctioning Endotracheal Tubes by Halyard Health: Class I Recall - Component May Detach During Use
An air leak between cuff and tracheal wall may reduce the amount of air that reaches the lungs. Use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death. (Source: FDA MedWatch)
Source: FDA MedWatch - December 31, 2014 Category: American Health Source Type: news
