An injection used to help premature infants with a heart problem has been recalled by the manufacturer because the vials may include bits of material that may provoke an immune reaction or an obstruction in the small arteries of the infants, which can be serious and life threatening.
The recalled device is the Indomethacin for Injection, USP, 1 mg Single Dose Vial, and is manufactured by Bedford Laboratories, a division of Ben Venue Laboratories, Inc. The particulate matter in the vials has been identified as active drug substance and not foreign material or contamination.
The Indomethacin for Injection is used to close a hemodynamically significant patent ductus arteriosis (PDA) in premature infants, who typically have small blood vessels. This condition occurs soon after birth in some babies. In PDA, abnormal blood flow occurs between two of the major arteries connected to the heart. This condition can put strain on the heart and increase blood pressure in the lung arteries.
Bedford Laboratories informed hospitals, emergency rooms, clinics, physician offices, and other health care facilities and providers of the problem, and told them not to use the products and to quarantine the products immediately. Bedford Laboratories is arranging for the return of the devices with its customers.
Any side effects this or any other medical device or drug should be reported to the Food and Drug Administration MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/report.htm.