FDA MedWatch

FDA is reviewing reports of serious liver injury, including liver failure.

Nationwide recall due to potential for needle to detach from syringe, become stuck in the vial, push back into syringe, or remain in skin after injection.

The agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.

Potential risks from Hospira, Inc. power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires.

Recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.

Cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept.

GDH-PQQ Glucose Monitoring Technology - possibility of falsely elevated blood glucose results when using GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) glucose test strips, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.

FDA notified healthcare professionals of an update to the Boxed Warning describing an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers.

Class 1 recall due to potential for patients experiencing under- or over-infusion, which may result in serious injury or death.

Class 1 recall due to damage to distal catheter shaft and risk of air embolism and myocardial infarction.