Urgent Recall: Fluorouracil Injection by Fresenius Kabi USA

PUBLISHED: Jul 2, 2019
Relevant to: All Healthcare Organizations

Fresenius Kabi USA, LLC is voluntarily recalling two lots of Fluorouracil Injection, USP 5g/100mL (50mg/mL), 100mL fill in 100mL vials, to the user level due to the potential for glass particulate.

  • Lot 6120341 and Lot 6120420 were distributed 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 second lot 6120420 is included in the recall as a precautionary measure as it was produced in the same filling campaign.

To date, Fresenius Kabi has not received any complaints or reports of adverse events related to this recall.

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 and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi.

The recall letter and response form are available at https://www.fresenius-kabi.com/us/documents/FK_USA_Fluorouracil_US_Recall_Packet_28JUN19.pdf

Consumers with questions regarding this recall may contact Fresenius Kabi at 1-800-551-7176 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. or via email at productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@freseniuskabi.com. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

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