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Popular Painkiller Ketorolac in Short Supply at Hospitals After Recall

Particulate matter found in vials

The generic painkiller ketorolac tromethamine injection, widely used in hospitals, is in short supply after its manufacturer, Hospira Inc., voluntarily recalled 63 lots of vials because of contamination by calcium-ketorolac crystals that could cause problems if injected into patients. The FDA announced the recall on February 10.

The affected lots were distributed in the U.S. from February 2013 to December 2014. Hospira has not received reports of adverse events associated with these lots to date. The company says it has initiated an investigation to determine the root cause and to formulate corrective and preventive actions.

The Lake Forest, Illinois, company has struggled to comply with manufacturing-quality requirements in recent years.

Health care facilities with an existing inventory of the affected product should stop use and distribution, and should quarantine the product immediately. Hospira has notified its customers of the recall by letter and is arranging for affected  products to be returned to Stericycle in the U.S. Those who have further questions regarding the recall should call Stericycle at 1-877-877-0164 between 8 a.m. and 5 p.m. Eastern Standard Time, Monday through Friday.

In its February 10 statement, the FDA said that there is no evidence indicating that intravenous or intramuscular injection of inert particles results in harm to patients when only a small amount is administered over a limited period, as is the case with ketorolac. Therapy may be delayed if particulates block the infusion of solution or if particulates are observed at the point of care. However, this delay is likely to be of negligible clinical significance as ketorolac is administered by a health care provider and remediation is readily available, the FDA said.

Sources: BioSpace; February 13, 2015; Pharmacy Times; February 12, 2015; and FDA; February 10, 2015.


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