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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3. February 2012
Posted in: FDA Alerts and Warnings
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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1. February 2012
Posted in: FDA Alerts and Warnings
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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31. January 2012
Posted in: FDA Alerts and Warnings
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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30. January 2012
Posted in: FDA Alerts and Warnings
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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20. January 2012
Posted in: FDA Alerts and Warnings
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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20. January 2012
Posted in: FDA Alerts and Warnings
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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20. January 2012
Posted in: FDA Alerts and Warnings
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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13. January 2012
Posted in: FDA Alerts and Warnings
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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12. January 2012
Posted in: FDA Alerts and Warnings
CardioGen-82 PET Scan: Drug Safety Communication – Increased Radiation Exposure
UPDATED 01/12/2012. FDA is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82.
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3. February 2012
Posted in: FDA Alerts and Warnings