Fluorouracil Injection

[15 August 2014]

Products Affected - Description

Fluorouracil injection 50 mg/mL, Fresenius Kabi (formerly APP)1
20 mL vial (NDC 63323-0117-20)
100 mL vial (NDC 63323-0117-61)
Fluorouracil injection 50 mg/mL, Mylan Institutional3
10 mL vial (NDC 10139-0063-11)
20 mL vial (NDC 10139-0063-12)
50 mL vial (NDC 10139-0063-50)
100 mL vial (NDC 10139-0063-01)
10 mL vial (NDC 00069-0169-02)
20 mL vial (NDC 00069-0173-02)
50 mL vial (NDC 00069-0174-01)
100 mL vial (NDC 00069-0176-01)
Fluorouracil injection 50 mg/mL, Teva2
50 mL vial (NDC 00703-3018-12)

Reason for the Shortage

  • Fresenius Kabi (formerly APP) states fluorouracil is on allocation to prevent excessive purchases.1
  • Teva has fluorouracil on back order due to manufacturing issues.2
  • Mylan Institutional temporarily discontinued their fluorouracil injection in May 2013.3
  • Mylan Institutional acquired fluorouracil injection from Pfizer on December 6, 2013.3

Available Products

Fluorouracil injection 50 mg/mL, Fresenius Kabi (formerly APP)1
10 mL vial (NDC 63323-0117-10)
50 mL vial (NDC 63323-0117-51)
Fluorouracil injection 50 mg/mL, Teva
10 mL vial (NDC 00703-3015-13)
100 mL vial (NDC 00703-3019-12)

Estimated Resupply Dates

  • Fresenius Kabi (formerly APP) is allocating fluorouracil 20 mL and 50 mL vials.1
  • Mylan Institutional has temporarily discontinued fluorouracil injection and the company does not have an estimated date for reintroduction. Mylan Institutional has the fluorouracil injection acquired from Pfizer on back order and the company cannot estimate a release date.3
  • Teva has fluorouracil 50 mL vials on back order with an estimated release date in mid-September 2014.2

Implications for Patient Care

  • Fluorouracil is a pyrimidine antimetabolite. It is labeled for the treatment of colon, rectal, breast, stomach, and pancreatic carcinomas in adult patients.4-6
  • Fluorouracil is used off-label in the treatment of head and neck, esophageal, anal, cervical, endometrial, ovarian, prostate, hepatic, bladder, and renal cell carcinomas. Fluorouracil is not labeled for use in pediatric patients; however, intravenous therapy has been used safely and effectively in this population.4-6


  • Chemotherapy agents, such as fluorouracil, pose additional safety risks both for patients and for healthcare workers handling these agents.4,5
  • Use additional caution when processing orders for chemotherapy drugs, especially when switching between chemotherapy agents or when processing orders for chemotherapy agents with which staff may be unfamiliar (eg, those not normally prescribed at a specific institution).4,5

Alternative Agents & Management

  • 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 fluorouracil.4-6
  • 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.
  • 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. 

Related Shortages


  1. Fresenius Kabi (formerly APP)1 (personal communications). May 26, June 1, 16, and 22, July 13 and 28, August 10 and 31, September 19, October 25, November 30, December 20, 2011; February 1 and 14, March 7, April 16, May 30, June 25, August 27, September 25, October 11, November 20 and 30, 2012; January 11, February 26, May 9, July 16, September 16, November 18, December 6, 2013; January 15, February 20 and 28, March 17, 18, and 25, April 4, 14, and 21, May 7, 19, and 28, June 10 and 17, July 9, and August 14, 2014.
  2. Teva (personal communications). May 26, July 13, August 9, October 27, November 30, December 21, 2011; and January 11, February 1 and 16, April 19, August 27, October 8, 2012; January 11, February 22, May 8, July 16, September 16, November 18, 2013; January 15, March 3 and 24, April 7, May 7, June 12, July 9, and August 15, 2014.
  3. Mylan Institutional [formerly Bioniche] (personal communications). May 26 June 24, July 11 and 28, August 9 and 31, October 28, November 30, December 21, 2011; January 11 and 31, February 17, March 7, April 19, May 30, June 22, August 21, September 24, October 10, December 5, 2012; January 11, February 27, May 8, July 16, September 16, November 18, December 9, 2013; January 9, February 20, March 3 and 24, May 7, and July 8, 2014. 
  4. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
  5. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
  6. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2010.


Updated August 15, 2014 by Kristin Jefferies, PharmD, Drug Information Specialist. Created May 27, 2011 by Megan Dryer, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.


This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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