From the category archives:

MedWatch

DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication – May Cause Severe Joint Pain

August 28, 2015

New information added to the WARNINGS AND PRECAUTIONS section of the drug labeling. 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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OmniPod (Pod) Insulin Management System by Insulet Corporation: Recall – Possibility of a Higher Rate of Failure

August 28, 2015

Use may result in interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis. 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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Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall – Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump

August 27, 2015

Over or under infusion of fluids to the patient has the potential to cause 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 [...]

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Hudson RCI Sheridan Sher-I-Bronch Endobroncial Tube by Teleflex Medical: Class I Recall – Connector May Crack or Separate

August 26, 2015

The connector may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress. 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 [...]

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Refresh Lacri-Lube, Refresh P.M., FML 0.1 Percent and Blephamide 10 Percent/0.2 Percent by Allergan: Recall – Particulate Matter

August 24, 2015

Potential adverse events may include eye pain, eye sewelling, ocular discomfort or eye irritation. 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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Picato (ingenol mebutate) Gel: Drug Safety Communication – FDA Warns of Severe Adverse Events, Requires Label Changes

August 21, 2015

Severe allergic reactions, skin rashes, & cases of shingles (herpes zoster reactivation) reported. Severe eye injuries and skin reactions have occurred when Picato gel is not applied according to recommendations in the label. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below [...]

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OxyTOTE Portable Oxygen Unit by Western/Scott Fetzer Company: Class I Recall – May Ignite and Burst

August 18, 2015

Reports of internal flash fire when the OxyTOTE is mishandled or dropped. 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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Prolotherapy with Phenol by Hartley Medical: Recall – Non-sterility Concerns

August 18, 2015

Parenteral administration of non-sterile injection products may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity, or a fatal outcome. 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. [...]

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Mammograms at Boston Diagnostic Imaging in Orlanda, Florida: FDA Safety Communication – Quality Problems

August 17, 2015

Patients should consider having their mammograms re-evaluated at a certified facility. 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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Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall – Catheter Tip May Slip or Separate

August 7, 2015

If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause 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 [...]

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