The discovery of visible particulates floating in a glass, flip-top vial of Hospira's ketorolac tromethamine injection, USP, has led the company to voluntarily recall several lots of the non-steroidal anti-inflammatory drug, says the FDA.
The 30 mg and 60 mg vials at issue were distributed in the United States between February 2013 and December 2014. Affected lot numbers are listed on this press release.
The particulate has been identified as crystallized calcium and ketorolac, and while the FDA has received no reports of adverse events arising from the contamination, it warns that injection of contaminated drugs could cause patient infections or blocked IV lines.