From the category archives:

MedWatch

Syrspend SF and Syrspend SF Grape Suspending Agents by Fagron: FDA Alert – Microbial Contamination with Yeast

February 10, 2016

If an immunocompromised patient or a child with an immature immune system ingests the contaminated product, there is a potential the patient will get an infection for which systemic antimicrobial therapy would be necessary. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link [...]

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Oxylog 2000 Plus, 3000, and 3000 Plus Emergency Transport Ventilators by Dräger Medical: Class I Recall – System Error May Lead to a Halt in Ventilation Therapy

February 10, 2016

If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including 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 [...]

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Pink Bikini and Shorts on The Beach Dietary Supplements by Lucy’s Weight Loss System: Recall – Undeclared Drug Ingredient

January 29, 2016

May contain sibutramine, phenolphthalein, and/or diclofenac. 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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Bentonite Me Baby – Bentonite Clay by Alikay Naturals: Consumer Warning – Risk of Lead Poisoning

January 28, 2016

Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. 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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SPOTCHEM II Test Strips by Arkray: Class I Recall – Inaccurate Blood Sugar Readings

January 28, 2016

Because the test strips are reporting falsely low blood glucose, there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) in a timely manner and fail to treat elevated blood glucose levels. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event [...]

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Moves Ventilator System by Thornhill Research: Class I Recall – Battery Problem

January 27, 2016

The issue may prevent the ventilator from providing patient breathing support and could 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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MOVES Ventilator System by Thornhill Research: Class I Recall – Battery Problem

January 27, 2016

The issue may prevent the ventilator from providing patient breathing support and could 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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Baxter IV Solutions (Select Lots): Recall – Potential for Leaking Containers and Particulate Matter

January 27, 2016

Solution contamination could lead to a worsened patient condition 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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Optisure Dual Coil Defibrillation Leads by St. Jude Medical: Class I Recall – Damage May Prevent Patient Therapy

January 26, 2016

Manufacturing error may have caused damage to the insulation layer of one of the shock coils. This could result in the inability of the defibrillator to deliver electrical therapy to the patient. 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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Licorice Coughing Liquid OTC Cough Syrup by Ma Ying Long Pharmaceutical Group: CDER Alert – Contains Unidentified Morphine

January 16, 2016

Effects of morphine can include, but are not limited to, severe allergic reactions, respiratory depression, 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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