Nationwide Recall of Two Lots of NeoProfen (ibuprofen lysine) Injection

Washington, DC: Lundbeck Inc has recalled two lots of NeoProfen (ibuprofen lysine) Injection that failed to meet a visible particulate quality requirement. These two lots are the only lots currently available to prescribers and therefore the recall will result in a temporary drug shortage. This voluntary recall is the result of the company's inspections of the two product lots of NeoProfen.

The NeoProfen recall, NDC 67386–122-52, includes product lots 1734991 (expiration date: April, 2011) and 1922319 (expiration date: March, 2012).

NeoProfen is a non-steroidal anti-inflammatory therapy indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective.

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 particulate matter include foreign body granulomas, and local irritation of blood vessels. 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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Published on Aug-2-10