From the category archives:

MedWatch

Super Extreme Accelerator: Public Notification – Undeclared Drug Ingredient

November 24, 2014

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The [...]

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Bee Thin: Public Notification – Undeclared Drug Ingredient

November 24, 2014

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The [...]

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Black Storm: Public Notification – Undeclared Drug Ingredient

November 24, 2014

Sildenafil 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 The [...]

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Bee Slim: Public Notification – Undeclared Drug Ingredient

November 24, 2014

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The [...]

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Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Recall – Complaints of Empty Capsules

November 24, 2014

Risk of missed dose(s) resulting in no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could 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 [...]

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Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall – Mislabeled Overpouch

November 21, 2014

Administration of a dose lower than intended, especially in patients prone to severe electrolyte imbalance, may lead to serious, life-threatening adverse health consequences. 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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Forever Beautiful Bee Pollen by REFA Enterprises: Recall – Undeclared Drug Ingredients

November 20, 2014

Risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke 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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Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall – Power Failure May Occur

November 19, 2014

Failure of power supply may cause ventilator to shut off, resulting in too much carbon dioxide or not enough oxygen in patient’s blood, 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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ABC Dophilus Powder by Solgar, Inc: Recall – Risk of Infection

November 17, 2014

The product was found to contain Rhizopus oryzae, which may cause health problems to consumers, particularly premature infants/infants, children, and those with weakened immune systems. 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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Long-term Antiplatelet Therapy: Safety Announcement – Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death

November 16, 2014

FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses. 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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