Blog Tags
Medical Devices
Healthy People Co. Dietary Supplements: Recall - Undeclared Drug Ingredient
Recalled products pose significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Categories: Medical Devices
Gris-PEG (griseofulvin ultramicrosize): Health Advisory - Risk of Product Mix-Up
During packaging and labeling, tablets from one product type may have carried over into packaging of another product.
Categories: Medical Devices
Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle
Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening.
Categories: Medical Devices
Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets
Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.
Categories: Medical Devices
Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans
Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).
Categories: Medical Devices
Treanda (bendamustine HCL): Recall - Particulate Matter in Vial
Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage.
Categories: Medical Devices
Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)
The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML.
Categories: Medical Devices
Perfect Image Solutions Topical Hair Regrowth Products: Recall - Unapproved Drugs, Risk of Health Hazards
Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms.
Categories: Medical Devices
Vagifresh Ball, Vagifresh Gel, Female One: Recall - Undeclared Drug Ingredient, Bacterial Contamination
Possibility of an adverse reaction or unknown drug-drug interaction.
Categories: Medical Devices
Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity
New Boxed Warning and Contraindication highlighting these risks added to product labeling.
Categories: Medical Devices
CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure
UPDATED 01/12/2012. FDA is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82.
Categories: Medical Devices
Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient
Failure of therapy could result in the potential for harm or death of a ventilator-dependent patient.
Categories: Medical Devices
Bedford Laboratories Polymyxin B For Injection USP And Vecuronium Bromide For Injection: Recall - Glass Particles
Particulate matter in injections can be harmful when introduced into the bloodstream.
Categories: Medical Devices
Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk
A packaging problem may result in a pill, tablet or caplet getting mixed in with a different prescription.
Categories: Medical Devices
Novartis Consumer Health Over-The-Counter Products: Recall - Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps
Consumers are asked to either destroy or return unused product identified in the recall to Novartis.
Categories: Medical Devices
Ikaria INOmax DS Drug Delivery System: Class I Recall - Erratic Nitric Oxide (NO) Readings
Adverse consequences may include hypoxia, hypotension, bradycardia, cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.
Categories: Medical Devices
CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation
Ventilator may stop ventilating and result in life-threatening injury or death.
Categories: Medical Devices
Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors
Additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available.
Categories: Medical Devices
Eclectic Institute Dietary Supplements: Recall - Possible Salmonella Contamination
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Categories: Medical Devices
ShoulderFlex Massager: Warning - Risk of Strangulation
Hair, clothing or jewelry can become entangled in the ShoulderFlex Massager and cause serious injury or even death from strangulation.
Categories: Medical Devices
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