FDA MedWatch

Cordis CROSSOVER Sheath Introducer - Recall

Nationwide recall due to complaints about stretching or fracture
of the sheath during use.

Accusure Insulin Syringes (Qualitest Pharmaceuticals) - Recall

Nationwide recall of all lots of product due to potential for needle to become detached from syringe during use.

Peramivir IV

Investigational antiviral drug approved for emergency use in H1N1 influenza infection; mandatory reporting of adverse events required by healthcare providers.

Rituxan (rituximab) - PML

Third case of PML reported, the first case of PML in a patient with rheumatoid arthritis treated with Rituxan who has not previously received treatment with a TNF antagonist.

Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall

Nationwide recall due to the potential for particulate matter in conjunction with crystallization in the product.

Dexferrum (iron dextran injection) - labeling change

Risk of anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection.

Relenza (zanamivir) Inhalation Powder

Drug must not be reconstituted in liquid formulation or used in any nebulizer or mechanical ventilator.

CT Brain Perfusion Scans Safety Investigation: Initial Notification

Initial Notification of risk of radiation overexposures during CT brain perfusion scans.

Unomedical Manual Pulmonary Resuscitator - Recall

Recall due to malfunction which impairs ability of device to generate positive pressure necessary to function properly.

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