German drugmaker Fresenius Kabi has made major investments in its U.S. manufacturing operations in recent years with some mixed quality results along the way. Now, one of the drugmaker's products faces a recall for more manufacturing woes.
Fresenius Kabi has recalled 13 lots of Ketorolac Tromethamine Injection after carbon, silicon, oxygen and polyamide particulates were found in eight vials of the anti-inflammation drug, the FDA said in an April 20 posting.
The recall covers 30- and 60-milligram doses of the drug distributed between May 5, 2018 and Dec. 16, the FDA said.
Fresenius has notified its distributor and customers of the recall and advised them "to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product."