Fresenius Kabi USA, LLC, is voluntarily recalling two lots of fluorouracil injection, USP 5 g/100 mL (50 mg/mL), 100 mL fill in 100 mL vials, to the user level because of the potential for glass particulate. The affected lots, distributed between December 6, 2018, and February 20, 2019, are listed below:
|Product Name/Size||NDC Number||Product Code||Lot Number||Expiration Date||First Ship Date||Last Ship Date|
USP, 5 g/100 mL (50 mg/mL), 100 mL
fill in a 100 mL vial
Products containing glass particulate should not be administered via IV because of 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.
To date, Fresenius Kabi has not received any complaints or reports of adverse events related to this recall.
The company issued the notification after finding glass particulate in five vials in retained sample inventory of lot 6120341 during an inspection for a quality investigation. The second lot (6120420) is included in the recall as a precautionary measure as it was produced in the same filling campaign.
Fluorouracil is a chemotherapy drug that is administered via IV and indicated for the treatment of a variety of cancers.
Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine, discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi.
Consumers with questions regarding the recall may contact Fresenius Kabi at 800-551-7176 Monday through Friday, from 8 am–5 pm, or via email at productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@freseniuskabi.com. Consumers should contact their physicians or healthcare providers if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online. Or for regular mail or fax, download the form or call 800-332-1088 to request a reporting form, then complete it and return to the address on the form or submit by fax to 800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.