From the category archives:

MedWatch

Baby Wipes by Nutek Disposables, Inc.: Recall – May Contain Bacteria

October 27, 2014

Those with weakened immune system or chronic lung disease may be more susceptible to infections with B. cepacia. 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 [...]

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Intravia Containers by Baxter: Recall – Particulate Matter

October 24, 2014

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. Posted 10/25/2014 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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Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall – Packaging Mix-Up

October 22, 2014

Risk of allergic reactions, from mild irritation or hives to serious reactions such as anaphylaxis that 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 The Original MedWatch [...]

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Saba Shark Cartilage Complex, 60 Capsule Bottles: Recall – Possible Salmonella Contamination

October 20, 2014

Salmonella can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. Posted 10/20/2014 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 [...]

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Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall – Particulate Matter

October 17, 2014

Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects. 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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September 2014

October 16, 2014

September 2014 Drug Safety Labeling Changes includes 55 products with revisions to Prescribing Information. 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 Flexible Intravenous Solutions by Hospira, Inc.: Recall – Potential for Leakage

October 15, 2014

A puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events. 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 [...]

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Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes by Covidien: Field Safety Alert – Electrodes Will Not Connect with Philips FR3 or FRx AED units

October 12, 2014

The mismatch of these devices could contribute to a delay in resuscitation and may contribute to subsequent 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 The Original MedWatch Notice [...]

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Sit and Slim II: Public Notification – Hidden Drug Ingredients

October 10, 2014

FDA analysis found these products to contain undeclared Sibutramine, which may increase blood pressure and/or pulse rate, and may also interact in life-threatening ways with other medications. 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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ICU Medical ConMed Stat2 Flow Controller: Class 1 Recall – Delivers Higher Flow Rate than Intended

October 10, 2014

Use of the affected product may cause serious adverse health consequences, including 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 The Original MedWatch Notice Here.

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