Archive | September, 2009
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.
Continue reading...Children’s and Infants’ Tylenol Oral Suspension Products – Recall
25. September 2009
Comments Off
Voluntary recall because of potential manufacturing problems.
Continue reading...Exjade (deferasirox) – Early Communication
25. September 2009
Comments Off
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).
Continue reading...Sitagliptin (marketed as Januvia and Janumet) – acute pancreatitis
25. September 2009
Comments Off
Cases of acute pancreatitis reported in patients treated with sitagliptin.
Continue reading...Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit
24. September 2009
Comments Off
Class I Recall due to possibility of obstruction or disruption of therapy. Posted 09/24/2009
Continue reading...Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm)
21. September 2009
Comments Off
Nationwide recall due to risk of obstruction and inability to ventilate patient.
Continue reading...Natalizumab (marketed as Tysabri)
17. September 2009
Comments Off
FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri.
Continue reading...Promethazine Hydrochloride Injection
16. September 2009
Comments Off
Boxed Warning added to labeling, describing risks of severe tissue injury, including gangrene, following intravenous administration of promethazine.
Continue reading...LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc)
16. September 2009
Comments Off
Class I recall due to failure or delay in delivery of therapy.
Continue reading...Covidien Pedi-Cap End-Tidal CO2 Detector
10. September 2009
Comments Off
Class I recall because the device may increase the resistance of the flow of air into the lungs, resulting in ineffective ventilation and the inability to verify the correct placement of a breathing tube when inserting it into the windpipe.
Continue reading...
29. September 2009
Comments Off