| 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. |
3-Feb-2012 |
| 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. |
3-Feb-2012 |
| 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. |
1-Feb-2012 |
| 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). |
31-Jan-2012 |
| 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. |
30-Jan-2012 |
| 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. |
20-Jan-2012 |
| 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. |
20-Jan-2012 |
| Vagifresh Ball, Vagifresh Gel, Female One: Recall - Undeclared Drug Ingredient, Bacterial Contamination |
Possibility of an adverse reaction or unknown drug-drug interaction. |
20-Jan-2012 |
| Adcetris (brentuximab vedotin): Drug Safety Communication - Progressive Multifocal Leukoencephalopathy and Pulmonary Toxicity |
New Boxed Warning and Contraindication highlighting these risks added to product labeling. |
13-Jan-2012 |
| 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. |
12-Jan-2012 |