Lundbeck’s intravenous anti-inflammatory ibuprofen lysine (NeoProfen) was recalled after high levels of visible particulate matter were found in samples of the drug.

The manufacturer voluntarily recalled two lots 1734991 and 1922319 with the expiration dates April 2011 and March 2012, respectively.

The visible particular matter found in the products can cause fetal reactions by blocking blood vessels and causing pulmonary emboli or triggering anaphylactic reactions. It can also irritate blood vessels and form granulomas.

No cases of illness related to the product have been reported.

NeoProfen is used for premature infants under 32 weeks who weigh from 500 to 1500g. The injectable ibuprofen is used when normal treatment is ineffective to treat ductus arteriosus.

The manufacturer said there will be a shortage of ibuprofen lysine as the affected lots were the only available sources of the drug. Under the FDA’s guidance, Lundbeck is carrying out the recall by informing product wholesalers, hospitals, and neonatologists.