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Class I Recall Active For Chemotherapy Injection


July 25, 2019

A Class I recall has been issued for more than 14,000 vials of Fresenius Kabi and Novaplus brand fluorouracil injection because of the potential presence of glass particulate, according to the July 24, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

“Products containing glass particulate should not be administered intravenously due to the potential for life-threatening consequences. Reports in the literature suggest that sequelae of thromboembolism, such as pulmonary emboli, phlebitis, granulomas, or fibrosis may occur,” maker Fresenius Kabi USA wrote in a company announcement. “To date, Fresenius Kabi has not received any complaints or reports of adverse events related to this recall.” 

The recall affects fluorouracil injection, 5 g/100 mL (50 mg/mL), 100 mL fill in a 100-mL vial, manufactured by Fresenius Kabi (Fresenius Kabi brand NDC 63323-117-61, Novaplus brand NDC 63323-117-69). The recalled injections are from lots 6120341(Exp. 4/20) and 6120420 (Exp. 4/20), which were distributed throughout the United States and in Puerto Rico between December 6, 2018, and February 20, 2019.  

“The company is issuing this notification after finding glass particulate in five vials in retained sample inventory of lot 6120341 during an inspection for a quality investigation,” the announcement explained. “The second lot (6120420) is included in the recall as a precautionary measure as it was produced in the same filling campaign.” 

Fresenius Kabi voluntarily initiated the recall June 28, 2019. On July 17, 2019, the FDA designated the recall Class I, which warns use of the affected product could cause serious adverse health consequences or death. 

Fluorouracil is a chemotherapy drug administered intravenously for the treatment of a variety of cancers. 

Jolynn Tumolo

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