Fresenius Kabi recalls anti-inflammation drug Ketorolac after finding particles in vials

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."

Fresenius has had a few troubled months after China's National Medical Products Administration in March suspended BeiGene's import and sale of cancer med Abraxane due to manufacturing concerns at a Fresenius plant in Illinois.

The agency said some key production equipment for the med didn’t meet basic quality control requirements, including aseptic management.

A Fresenius spokesperson said the findings were “general in nature and relate to room classification and process flow/material movement that do not have any impact on product safety,” adding that there's “no field safety corrective action with this product in the Chinese market.”

The German company in April 2018 held a topping out ceremony for a $250 million expansion of the Illinois site. That decade-long project includes new buildings for aseptic filing lines, expanded lyophilization capabilities and formulation areas, plus a warehouse.

Fresenius around the same time invested $100 million into its Wilson, North Carolina plant. The expansion, slated to be finished in 2022, promised to add 445 jobs. Fresenius makes prefilled syringes at the site, which it acquired from Becton Dickinson in 2017.

May 7, 2020

https://www.fiercepharma.com/

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