Archive for the ‘MedWatch Safety Alerts’ Category

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

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

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

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

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

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

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)

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

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

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

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

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