From the category archives:

MedWatch

Gris-PEG (griseofulvin ultramicrosize): Health Advisory – Risk of Product Mix-Up

February 3, 2012

During packaging and labeling, tablets from one product type may have carried over into packaging of another 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 [...]

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Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall – Visible Glass Particle

February 3, 2012

Use of an inhaled product with glass particles has the potential to cause choking which 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 notice. View Full Details Of The Original MedWatch Notice [...]

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Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall – Possibility of Inexact Tablet Counts or Out of Sequence Tablets

February 1, 2012

Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. 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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Vitaflo USA Renastart: Recall – Possible Health Risk Due To Incorrectly Labeled Cans

January 31, 2012

Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia). 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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Treanda (bendamustine HCL): Recall – Particulate Matter in Vial

January 30, 2012

Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage. 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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Tysabri (natalizumab): Drug Safety Communication – New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)

January 20, 2012

The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. [...]

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Perfect Image Solutions Topical Hair Regrowth Products: Recall – Unapproved Drugs, Risk of Health Hazards

January 20, 2012

Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms. 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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Vagifresh Ball, Vagifresh Gel, Female One: Recall – Undeclared Drug Ingredient, Bacterial Contamination

January 20, 2012

Possibility of an adverse reaction or unknown drug-drug interaction. 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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Adcetris (brentuximab vedotin): Drug Safety Communication – Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity

January 13, 2012

New Boxed Warning and Contraindication highlighting these risks added to product 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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Respironics, Inc. Trilogy 100 Ventilators: Class I Recall – Device May Stop Delivering Therapy to Patient

January 12, 2012

Failure of therapy could result in the potential for harm or death of a ventilator-dependent patient. 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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