From the category archives:

MedWatch

Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication – FDA Cautions About Dose Confusion and Medication Errors

May 20, 2015

Can lead to to administration of more drug than was prescribed. 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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Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication – FDA Cautions about Dose Confusion and Medication Errors

May 19, 2015

Can lead to to administration of more drug than was prescribed. 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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SGLT2 inhibitors: Drug Safety Communication – FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood

May 15, 2015

High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015 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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LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira: FDA Safety Communication – Security Vulnerabilities

May 12, 2015

An unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers, which could lead to over- or under-infusion of critical therapies. 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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Tiger Paw System II by Maquet Medical Systems: Class I Recall – May Cause Tears and Bleeding in Heart Tissue

May 7, 2015

Possibility of a tear on the left atrial wall during use of the device. 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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Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall – Particulate Matter

May 5, 2015

Administration of product with particulate matter has potential to result in inflammation, allergic reactions, or blockage of blood vessels, 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 link below will take you to the [...]

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Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication – Quality Problems

April 30, 2015

Patients may need a repeat mammogram or additional medical follow-up. 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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Injectable Products by Mylan: Recall – Presence of Particulate Matter

April 24, 2015

Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. 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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Bupivacaine HCl Injection by Hospira: Recall – Iron Oxide Particulate In Glass Vials

April 24, 2015

Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue. 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 [...]

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Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall – Not Cleared for Marketing

April 22, 2015

The results obtained from these test kits have not been demonstrated to be accurate and should not be used as diagnostic tests for Ebola infection. Posted 04/23/2015 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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