From the category archives:

MedWatch

Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems: Class I Recall – Sheath May Fracture During Use

August 19, 2014

Fragments of the sheath could possibly block blood vessels. 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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Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall – Presence of Particulate Matter

August 15, 2014

Particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to 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. View Full Details [...]

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IPM Wound Gel by Edwards Pharmaceuticals: Class I Recall – Microbial Contamination

August 12, 2014

Use of the affected product may cause serious adverse health consequences, including sepsis, limb loss, and 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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Arize: Public Notification – Undeclared Drug Ingredient

August 11, 2014

Undeclared sulfoaildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. 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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Herbal Vigor Quick Fix: Public Notification – Undeclared Drug Ingredient

August 11, 2014

Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. 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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CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall – Foreign Particulate Matter

August 8, 2014

Administration of particulate matter poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. 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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White and Blue Lion Tattoo Kits: Recall – Bacterial Contamination of Needles and Ink Bottles

August 8, 2014

Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection. 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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RegenESlim Appetite Control Capsules: Recall – Presence Of DMAA

August 7, 2014

DMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will [...]

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RegeneSlim Appetite Control Capsules: Recall – Presence Of DMAA

August 7, 2014

DMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will [...]

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Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall – Presence Of Particulate Matter

August 7, 2014

The administration of a glass particulate poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli. 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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