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FDA News Alerts

Healthy People Co. Dietary Supplements: Recall
Recalled products pose significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

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

Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall
Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening.

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

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

Treanda (bendamustine HCL): Recall
Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage.

Tysabri (natalizumab): Drug Safety Communication
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.

Perfect Image Solutions Topical Hair Regrowth Products: Recall
Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms.

Vagifresh Ball, Vagifresh Gel, Female One: Recall
Possibility of an adverse reaction or unknown drug-drug interaction.

Adcetris (brentuximab vedotin): Drug Safety Communication
New Boxed Warning and Contraindication highlighting these risks added to product labeling.

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Recall News
YAZ-YASMIN ALERT

The best selling birth control pill, Yaz, and its predecessor, Yasmin, have been linked to serious side effects. If you or someone you know has suffered blood clots, pulmonary embolism, hyperkalemia (elevated potassium levels), hypertension, seizures/convulsions or kidney problems after taking Yaz or Yasmin, you should contact a Yaz Lawyer.

Product Recall
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The Peterson Foundation, Inc. was established by David M. Peterson to support children in need throughout the Kansas City area. For more information click here.

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