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FDA: NeoProfen Recalled Due to Visible Particulate Matter

Lundbeck Inc. recalls two lots of the drug, which may result in temporary product shortage

TUESDAY, Aug. 3 (HealthDay News) -- The U.S. Food and Drug Administration has alerted health care professionals of a voluntary recall of two lots of Lundbeck Inc.'s ibuprofen lysine (NeoProfen) injection, as the product did not meet a visible particulate quality requirement.

Ibuprofen lysine is a nonsteroidal anti-inflammatory agent used to treat clinically significant patent ductus arteriosus in premature infants when standard medical management strategies fail. The two product lots included in the recall are 1734991 (expiration date: April 2011) and 1922319 (expiration date: March 2012), which are the only two lots available to prescribers; therefore, there will likely be a temporary shortage until the manufacturer replenishes ibuprofen lysine stock.

Lundbeck has not received any adverse event reports or product complaints associated with any lots of ibuprofen lysine. The presence of particulate matter may be associated with adverse events, including foreign body granulomas and local irritation of blood vessels as well as obstruction of blood vessels that could induce pulmonary emboli or activate platelets and/or neutrophils to stimulate anaphylactic reactions.

According to a Lundbeck press release, "the potential adverse events resulting from the use of a sterile injectable product with particulates can be very serious and potentially fatal. As such, the company is conducting a voluntary recall as a safety precaution, and will continue to closely monitor for reports of adverse drug reactions and product complaints."

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