FDA MedWatch

Philips Heartstart Fr2+ Automated External Defibrillators - Recall

Nationwide recall due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated.

Neuron 6F 070 Delivery Catheter [Penumbra]

Field removal of the catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter

Heparin: Change in Reference Standard

The change will result in 10% reduction in the potency of the heparin marketed in the U.S. and may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important

Neocate Infant Specialized Formula - Recall

Nationwide recall of Neocate Infant Specialized Formula, Lot # P91877, due to a manufacturing error that resulted in protein levels lower than that declared on the label.

Children's and Infants' Tylenol Oral Suspension Products - Recall

Voluntary recall because of potential manufacturing problems.

Exjade (deferasirox) - Early Communication

Early Communication describing an increased number of adverse events and deaths in patients using Exjade who are over sixty years old who have myelodysplastic syndrome (MDS).

Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis

Cases of acute pancreatitis reported in patients treated with sitagliptin.

Tamiflu for Oral Suspension: Potential Medication Errors

Pharmacists and pediatrics healthcare profesionals notified of risk of medication dosing errors

Natalizumab (marketed as Tysabri)

FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri.

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