Products Affected - Description

• • Fluorouracil injection, Accord, 50 mg/mL, 10 mL vial, 10 count, NDC 16729-0276-68
  • Fluorouracil injection, Accord, 50 mg/mL, 20 mL vial, 10 count, NDC 16729-0276-67
  • Fluorouracil injection, Accord, 50 mg/mL, 50 mL vial, 1 count, NDC 16729-0276-11
  • Fluorouracil injection, Sagent, 50 mg/mL, 100 mL vial, 1 count, NDC 25021-1215-99
  • Fluorouracil injection, Sagent, 50 mg/mL, 50 mL vial, 1 count, NDC 25021-1215-98
  • Fluorouracil injection, Xiromed, 50 mg/mL, 10 mL vial, 10 count, NDC 70700-0186-23
  • Fluorouracil injection, Xiromed, 50 mg/mL, 100 mL vial, 1 count, NDC 70700-0189-22
  • Fluorouracil injection, Xiromed, 50 mg/mL, 20 mL vial, 10 count, NDC 70700-0187-23
  • Fluorouracil injection, Xiromed, 50 mg/mL, 50 mL vial, 1 count, NDC 70700-0188-22

Reason for the Shortage

• • Accord has fluorouracil injection on shortage due to manufacturing delays.
  • Alembic has fluorouracil injection available.
  • Fresenius Kabi has fluorouracil injection available.
  • Sagent did not provide a reason for the shortage.
  • Xiromed did not provide a reason for the shortage.

Available Products

• • Fluorouracil injection, Accord, 50 mg/mL, 100 mL vial, 1 count, NDC 16729-0276-38
  • Fluorouracil injection, Alembic, 50 mg/mL, 100 mL vial, 1 count, NDC 62332-0779-31
  • Fluorouracil injection, Alembic, 50 mg/mL, 50 mL vial, 1 count, NDC 62332-0751-50
  • Fluorouracil injection, Fresenius Kabi, 50 mg/mL, 10 mL vial, 10 count, NDC 63323-0117-10
  • Fluorouracil injection, Fresenius Kabi, 50 mg/mL, 100 mL vial, 1 count, NDC 63323-0117-61
  • Fluorouracil injection, Fresenius Kabi, 50 mg/mL, 20 mL vial, 10 count, NDC 63323-0117-20
  • Fluorouracil injection, Fresenius Kabi, 50 mg/mL, 50 mL vial, 1 count, NDC 63323-0117-51

• • Accord has fluorouracil 50 mg/mL 10 mL, 20 mL, and 50 mL vials on back order and the company cannot estimate a release date.
  • Sagent has fluorouracil 50 mg/mL 50 mL and 100 mL vials on back order and the company estimates a release date of April 2024.
  • Xiromed has fluorouracil 50 mg/mL 10 mL, 20 mL, 50 mL, and 100 mL vials on allocation to current customers.

• • Consider evaluating the health-care system's total supply of fluorouracil before beginning patients on combination chemotherapy regimens containing fluorouracil. If adequate supplies are not available, select an alternative regimen.
  • The choice of an alternative agent must be patient-specific and based on renal function, liver function, and the neoplasm type and location. No single agent can be substituted for flourouracil.
  • Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations.
  • Refer to the ASHP Guidelines on Managing Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/managing-drug-product-shortages.pdf
  • Refer to national guidelines such as those from the National Comprehensive Cancer Network (www.nccn.org) or American Society of Clinical Oncology (http://www.asco.org/) for additional information regarding therapeutic use.