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Fresenius Kabi recalls chemotherapy drug because of possible glass particulate within the drug vials.
Fresenius Kabi USA announced on July 1, 2019 that it was recalling two lots of Fluorouracil Injection USP 5 g/ 100 mL, 100 mL fill in 100mL vials to the user level because of possible glass particulate within the drug vials. The company reported that glass particulate was found in five vials during a quality inspection of one lot of the drug product. A second lot produced in the same filling campaign was included in the recall as a precautionary measure.
Using drug products containing glass particulate could cause a sequelae of thromboembolism, such as pulmonary emboli, phlebitis, granulomas, or fibrosis, according to the company.
The recalled lots, numbers 6120341 and 6120420 were distributed between Dec. 6, 2018 and Feb. 20, 2019 and have expiration dates of April 2020.
Fresenius Kabi is asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.
Fluorouracil Injection is an intravenous chemotherapy drug that treats an array of cancers.
The recall notice was announced by Fresenius Kabi on the FDA website.