From the category archives:

MedWatch

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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CareFusion EnVe and ReVel Ventilators: Class 1 Recall – Power Connection Failure

October 10, 2014

Ventilator shut-off from power failures may lead to serious 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 The Original MedWatch Notice Here.

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Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall – Uncontrolled Storage During Transit

October 8, 2014

One lot may have experienced temperature excursions during shipment. 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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Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex Medical: Class I Recall – Circuit Ends May Crack or Break

October 7, 2014

Defect could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately. 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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Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall – Incorrect Labeling

October 6, 2014

The labeled expiration date is longer than the known stability of the product. 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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