Tag Archive | "FDA Warning"

Healthy People Co. Dietary Supplements: Recall – Undeclared Drug Ingredient

Monday, February 6, 2012

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Recalled products pose significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

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

Friday, February 3, 2012

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

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

Friday, February 3, 2012

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Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening.

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

Wednesday, February 1, 2012

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Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

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Vitaflo USA Renastart: Recall – Possible Health Risk Due To Incorrectly Labeled Cans

Tuesday, January 31, 2012

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Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).

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Treanda (bendamustine HCL): Recall – Particulate Matter in Vial

Monday, January 30, 2012

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Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage.

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Tysabri (natalizumab): Drug Safety Communication – New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)

Friday, January 20, 2012

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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.

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

Friday, January 20, 2012

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Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms.

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Vagifresh Ball, Vagifresh Gel, Female One: Recall – Undeclared Drug Ingredient, Bacterial Contamination

Friday, January 20, 2012

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Possibility of an adverse reaction or unknown drug-drug interaction.

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Adcetris (brentuximab vedotin): Drug Safety Communication – Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity

Friday, January 13, 2012

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New Boxed Warning and Contraindication highlighting these risks added to product labeling.

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