Nellcor Puritan Bennett 980 Ventilator System by Covidien: Class I Recall - Component Failure May Cause Burning Odor
Problems in the manufacturing process may lead to unexpected need to stop the ventilator and transfer the patient to another ventilator. (Source: FDA MedWatch)
Source: FDA MedWatch - December 31, 2014 Category: American Health Source Type: news
IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients
There have been reports of serious adverse events associated with the use of certain of these products. (Source: FDA MedWatch)
Source: FDA MedWatch - December 31, 2014 Category: American Health Source Type: news
Caramel Apples: Warning - Illnesses, Including Deaths, Linked to Listeria Monocytogenes Contamination
Listeriosis can be fatal, especially in certain high-risk groups, including the elderly, and people with weakened immune systems and certain chronic medical conditions (such as cancer). (Source: FDA MedWatch)
Source: FDA MedWatch - December 26, 2014 Category: American Health Source Type: news
Mitoxantrone by Hospira: Recall - Confirmed Subpotency and Out-Of-Specification
Potential for decreased potency which can lead to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity requiring medical intervention. (Source: FDA MedWatch)
Source: FDA MedWatch - December 24, 2014 Category: American Health Source Type: news
SLIM-K Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredients
Can increase blood pressure and/or pulse rate, interact in life threatening ways with other medications, casue serious GI disturbances, irregular heartbeat, and cancer with long-term use. (Source: FDA MedWatch)
Source: FDA MedWatch - December 22, 2014 Category: American Health Source Type: news
B-Lipo Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredient
Serious adverse events, which may be life-threatening, include damage to the heart valve, or
serotonin syndrome particularly if taken with other medications that work similarly. (Source: FDA MedWatch)
Source: FDA MedWatch - December 22, 2014 Category: American Health Source Type: news
0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter
Intravenous administration of a solution containing particulate matter may lead to local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization. (Source: FDA MedWatch)
Source: FDA MedWatch - December 16, 2014 Category: American Health Source Type: news
Ziprasidone (Marketed as Geodon and Generics): Drug Safety Communication - Rare But Potentially Fatal Skin Reactions
Symptoms may include a rash that can spread to all parts of the body, fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas. (Source: FDA MedWatch)
Source: FDA MedWatch - December 11, 2014 Category: American Health Source Type: news
Dietary Supplements Containing Live Bacteria or Yeast in Immunocompromised Persons: Warning - Risk of Invasive Fungal Disease
FDA advises practitioners to approach the application of these interventions with caution. (Source: FDA MedWatch)
Source: FDA MedWatch - December 9, 2014 Category: American Health Source Type: news
Heart Sync Inc. Multi-function Defibrillation Electrodes: Device Correction - Connector Incompatibility with Philips FR3 and FRx Defibrillator Units
May result in a delay in therapy. (Source: FDA MedWatch)
Source: FDA MedWatch - December 3, 2014 Category: American Health Source Type: news
Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels: Class I Recall - May Produce Incorrect Results
Using these recalled devices may cause ineffective patient treatment. (Source: FDA MedWatch)
Source: FDA MedWatch - December 2, 2014 Category: American Health Source Type: news
CONMED PadPro and R2 Multi-function Defibrillation Electrodes: Device Correction - Connector Compatibility Issue With Philips FR3 and FRx Defibrillator Units
May result in a delay in therapy. (Source: FDA MedWatch)
Source: FDA MedWatch - November 26, 2014 Category: American Health Source Type: news
Slim-Vie: Public Notification - Undeclared Drug Ingredient
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. (Source: FDA MedWatch)
Source: FDA MedWatch - November 26, 2014 Category: American Health Source Type: news
Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported
Symptoms of PML may include: progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; and changes in thinking, memory and orientation. The progression of deficits can lead to severe disability or death. (Source: FDA MedWatch)
Source: FDA MedWatch - November 25, 2014 Category: American Health Source Type: news
Super Extreme Accelerator: Public Notification - Undeclared Drug Ingredient
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. (Source: FDA MedWatch)
Source: FDA MedWatch - November 24, 2014 Category: American Health Source Type: news
