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Fluorouracil Injection, BP (5-fluorouracil) 5 g / 100 mL - Risk of Breach in Sterility and/or Exposure due to Vial Breakage or Leakage

Starting date:
October 21, 2016
Posting date:
March 6, 2017
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-60664

UPDATED INFORMATION - March 3, 2017

In light of the current reported shortage of this drug, and as an interim measure, Health Canada facilitated the release of 3608 vials of FLUOROURACIL on March 6, 2017. The vials had previously been quarantined by the company due to the risk associated with the possibility of cracked or leaking vials, as described in this October 2016 risk communication. Health Canada will continue to monitor the situation.

Healthcare professionals need to visually inspect all vials for clarity, particulate matter, precipitate, discolouration, cracks and leakage prior to administration. Vials that show cracks, leakage, or white powder outside the vial should not be used.

Audience

Oncologists, Hospital Pharmacists, Oncology Nurses, Pharmacy technicians

Key messages

  • Accord Healthcare Canada Inc. and Health Canada have identified broken or leaking vials of Fluorouracil Injection, BP 5 g / 100 mL, a potent cytotoxic drug. Sterility of contents of the cracked or leaking vials could be compromised.
  • Inadvertent exposure of healthcare professionals to 5-fluorouracil from leaking vials may lead to serious adverse reactions.
  • As with all parenteral drug products, healthcare professionals need to visually inspect all vials for clarity, particulate matter, precipitate, discoloration, cracks and leakage prior to administration, whenever solution and container permit.
  • In cases of breakage/leakage, an accumulation of a white powder will appear outside of the vial. Vials that show cracks, leakage, or white powder on the outside of the vial should not be used.

   

Issue

Between June 2015 and October 19, 2016, Accord Healthcare Canada Inc. discovered and rejected 14 leaking vials of Fluorouracil Injection, BP 5 g/ 100 mL from 5 lots (out of 43 lots comprising of 77,864 vials) released during this time period). These affected vials were not released onto the Canadian market.

Products affected

Fluorouracil Injection, BP
Format/Strength: vials of 100 mL; 50 mg / mL (5 g /100 mL)
DIN: 02413450
Product code: 50101
All lots from Accord Healthcare Canada Inc.

Background information

Fluorouracil Injection, BP 5 g / 100 mL is indicated in the palliative treatment of colorectal carcinoma and carcinoma of the breast, and in the treatment of carcinoma of the stomach, pancreas, prostate, ovary, bladder and head and neck, either as a single agent or in combination with radiation therapy and/or other chemotherapeutic agents.

Risks associated with a cracked or leaking vial of 5-fluorouracil include: breach of sterility of the contents of the cracked or leaking vial, decrease in the amount of drug substance in the vial leading to decreased dose administration and decreased efficacy, injury from broken glass to the healthcare professional handling the vial and inadvertent exposure of the healthcare professional to 5-fluorouracil from a leaking vial.

Published studies have shown that workplace exposures to hazardous drugs can cause both acute and chronic health effects such as skin rashes, adverse reproductive outcomes (including infertility, spontaneous abortions, and congenital malformations), and possibly leukemia and other cancers. The health risk depends on how much exposure a worker has to these drugs and how toxic they are.

During a visual inspection of all vials of Fluorouracil Injection, BP, Accord noted a minor number of vials that had leaked during transportation.

Accord Healthcare Canada has implemented visual inspection of every lot being released on the Canadian market. However, small cracks under the cap or aluminium seal may not be visible.

Who is affected

Information for healthcare professionals

Fluorouracil is a potent and cytotoxic drug and should be administered by, or under supervision of, a physician who is experienced in cancer chemotherapy.  The vials are wrapped with PharmaShield®, a system consisting of an external plastic sheathing around the vial, going from the reinforced non-PVC base to the vial seal.  PharmaShield® provides greater stability during manipulation and further reduced risk of breakage if the vial is dropped.

This product contains 5-fluorouracil at a concentration that is close to saturation.  In cases that vials would leak, an accumulation of a white powder will appear outside of the vial but should be retained by the PharmaShield®.

In the event of cracks, breakage or leakage, contact Accord to assess the appropriate return procedure to Accord.  The contact information are provided at the boxed text further below.

Healthcare professionals should refer to the Fluorouracil Injection, BP 5 g / 100 mL Canadian Product Monograph for special instructions for handling cytotoxic drugs.

Action taken by Health Canada

Health Canada is communicating this important safety information to healthcare professionals via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site . This communication will be further distributed through the MedEffect e-Notice email notification system.  Health Canada and Accord Healthcare Canada Inc. are monitoring the situation and will implement corrective and preventative actions as necessary.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of unintended exposure due to vial leakage or breakage or other serious or unexpected side effects in patients receiving Fluorouracil Injection 5 g / 100 mL should be reported to Accord Healthcare Inc. or Health Canada.

Accord HealthCare Inc.
3535 Boul. St-Charles (suite 704)
Montréal, Québec
H9H 5B9
1-866-296-0354

To correct your mailing address or fax number, contact Accord Healthcare Inc.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or
  • Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Regulatory Operations and Regions Branch
E-mail: dcviu_uvcem@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

We apologize for any inconvenience which this situation may cause.

Sincerely yours,

Original signed by

Michel Charbonneau
Executive Vice-president

Charles Vachon, M.Sc., MBA
Director, Quality and Regulatory Affairs

For more information

The manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.