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Lundbeck Voluntarily Recalls NeoProfen Injection

PBR Staff Writer Published 02 August 2010

Lundbeck has voluntarily recalled two lots of NeoProfen (ibuprofen lysine) injection as they failed to meet a visible particulate quality requirement which was found in an inspection of the two product lots of NeoProfen conducted by the company. The recall is being conducted with the knowledge of FDA.

The two lots that Lundbeck recalled are the only lots currently available to prescribers and therefore the recall will result in a temporary drug shortage.

Lundbeck's recall of NeoProfen 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 patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500g, who are no more than 32 weeks gestational age when usual medical management such as fluid restriction, diuretics, respiratory support, is ineffective.

Lundbeck stated that the particulate matter has the possibility to obstruct blood vessels which could induce pulmonary emboli or activate platelets and/or neutrophils to induce anaphylactic reactions.

Additionally, intravenous injection of particulate matter may result in foreign body granulomas, and local irritation of blood vessels. The adverse events resulting from the use of a sterile injectable product with particulates can be very serious and potentially fatal.

Hence, Lundbeck is taking a precautionary measure by conducting a voluntary recall and is expected to closely monitor for reports of adverse drug reactions and product complaints.