Another day of recalling. This time on NeoProfen, which is an injectable ibuprofen.
This is a form of non-steroidal anti-inflammatory which is used in neonates with patent ductus arteriosus. In this congenital malformation, there is aberrant blood flow between the aorta and pulmonary artery. This type of blood flow is actually normal in fetal anatomy, but the connection normally closes soon after birth. The abnormality is relatively common in the United States, occurring in 8 per 1000 births.
The injectable medication in question has a specific patient profile, including gestational age and weight. In this case, the medication did not meet a quality standard, and this recall will result in a shortage, since the lots that are being recalled are the only lots available.
People that need to know: parents of patients, pediatricians, neonatal cardiologists, pediatric surgeons, and anesthesiologists.