Ibuprofen Lysine Lots Recalled Due to Particulate Matter

Emma Hitt, PhD

August 02, 2010

August 2, 2010 — Two lots of ibuprofen lysine injection (NeoProfen; Lundbeck, Inc), representing the entire supply of this agent, are being voluntarily recalled because of the presence of a visible particulate, according to a manufacturer's press release issued July 30.

The 2 lots involved in the recall are 1734991, with an expiration date of April 2011, and 1922319, with an expiration date of March 2012.

According to the manufacturer, the voluntary recall is the result of the company's inspections of the 2 product lots of NeoProfen and will result in the temporary shortage of this agent.

"To date, the company has not received adverse event reports or product complaints attributable to visible particulates from any lot of NeoProfen, including the lots that are being recalled," the press release states.

According to the manufacturer, potential adverse events that could occur from particulate matter include those attributable to obstructed blood vessels, including pulmonary emboli, anaphylactic reactions, 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," according to Lundbeck. "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."

Ibuprofen lysine injection is a nonsteroidal anti-inflammatory therapy indicated to close a clinically significant patent ductus arteriosus in premature infants, weighing between 500 and 1500 g and of no more than 32 weeks' gestational age, when usual medical management is ineffective.

Clinicians with questions may contact the manufacturer by telephone at 1-866-402-8520 or by email at luinc-druginfo@lundbeck.com. Product complaints related to NeoProfen should be reported by telephone at 1-800-455-1141, by fax at 1-847-282-1003, or by email at luinc_safety@lundbeck.com.

More information on the recall is available on the FDA's Web site.

Adverse events related to ibuprofen lysine should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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