From the category archives:

MedWatch

Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall – Particulate Matter

July 27, 2015

Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The [...]

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Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication – FDA Evaluating the Risk of Brain Deposits With Repeated Use

July 27, 2015

Health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of [...]

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Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall – Lack of Sterility Assurance

July 24, 2015

If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of [...]

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0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall – Particulate Matter

July 19, 2015

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. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take [...]

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Proglycem (diazoxide): Drug Safety Communication – Reports of Pulmonary Hypertension in Infants and Newborns

July 16, 2015

Monitor patients, especially those with risk factors for pulmonary hypertension, for signs of respiratory distress, including tachypnea, flaring nostrils, grunting, and chest wall retractions. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full [...]

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Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal – Difficulties in Administration

July 13, 2015

Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal – Difficulties in Administration This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

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Lariat Suture Delivery Device for Left Atrial Appendage (LAA) Closure by SentreHEART: FDA Safety Communication – Reports of Patient Deaths and Other Serious Adverse Events

July 13, 2015

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. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View [...]

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Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication – FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke

July 9, 2015

Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original [...]

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Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall – Intake Port Blockage

July 2, 2015

Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of [...]

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Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality

July 1, 2015

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. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original [...]

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