Select vials of NeoProfen (ibuprofen Lysine), an injectable non-steroidal anti-inflammatory therapy used to treat a congenital heart disorder in premature infants, has been recalled by the Food and Drug Administration (FDA) because particulate matter was found floating in the medication. Particulate matter has the potential to obstruct blood vessels and could cause serious and potentially fatal complications. This recall will cause a temporary shortage in hospitals, the FDA reports.

NeoProfen is indicated to close a clinically significant blood vessel in the heart known as patent ductus arteriosus, in premature infants weighing between 500 and 1,500 grams, who are more than 32 weeks gestational age when usual medical management, such as fluid retention, diuretics and respiratory support, is ineffective.

The recall was initiated after the manufacturer of NeoProfen, Lundbeck Inc., inspected some lots of the medication and it failed to meet a visible particulate quality requirement. The recall includes lots 1734991 (expiration date: April, 2011) and 1922319 (expiration date: March, 2012). This recall will cause a temporary drug shortage. The FDA has drug shortage management information for hospitals.

Particulate matter has the potential to obstruct blood vessels which could induce pulmonary emboli or activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with intravenous injection of the particulate matter include foreign body granulomas, and local irritation of blood vessels. The potential events resulting from the use of a sterile injectable product with particulates can be very serious and potentially fatal. To date, Lundbeck has not received adverse event reports or product complaints attributed to the visible particulates from any lot of NeoProfen, including the lots that are being recalled.

Any adverse events with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch <http://www.FDA.gov/MedWatch> .