NeoProfen Injection Recall Issued Due to Visible Particulates

All currently available lots of NeoProfen (ibuprofen lysine) Injection have been recalled because they failed to meet visible particulate quality requirements, which could cause serious and potentially life-threatening health problems.

The NeoProfen injection recall was issued on Friday by Lundbeck, Inc., involving two lots of the drug. These are the only two lots currently available to prescribers, so the recall will result in a temporary drug shortage.

NeoProfen is an ibuprofen lysine injection that is approved to treat premature infants weighing between 1 pound 2 ounces and 3 pounds 5 ounces (500 grams to 1500 grams) who are no more than 32 weeks gestational age. The non-steroidal anti-inflammatory therapy is used to close clinical significant patent ductus arteriosus (PDA) when usual medical management, such as fluid restriction, diuretics and respiratory support, are ineffective.

Although there have been no adverse events reported in association with the visible particulate matter in NeoProfen Injections, the manufacturing problems could obstruct blood vessels and induce pulmonary emboli or activate platelets and neutrophils to induce anaphylactic reactions. Other problems from particulate matter in NeoProfen Injection could include foreign body granulomas and local irrittation of blood vessels.

Lundbeck, Inc. indicates that they will continue to closely monitor for reports of adverse drug reactions and product complaints, as the use of injectable products with particulats can be very serious and potentially life-threatening.

Product complaints related to the NeoProfen recall should be reported to Lundbeck by calling (800) 455-1141, and by making a report with the FDA’s MedWatch Program at http://www.fda.gov/safety/medwatch/default.htm.