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.
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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
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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
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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.
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Children's and Infants' Tylenol Oral Suspension Products - Recall
Voluntary recall because of potential manufacturing problems.
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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).
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Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis
Cases of acute pancreatitis reported in patients treated with sitagliptin.
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Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit
Class I Recall due to possibility of obstruction or disruption of therapy. Posted 09/24/2009
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Tamiflu for Oral Suspension: Potential Medication Errors
Pharmacists and pediatrics healthcare profesionals notified of risk of medication dosing errors
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Natalizumab (marketed as Tysabri)
FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri.
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