Cytarabine Injection - Crystallization in 2 g/20 mL (100 mg/mL) Vials - For Health Professionals

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Contact: Health Product and Food Branch Inspectorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Hospira Healthcare Corporation.
Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on Cytarabine Injection in 2 g/ 20 mL (100mg/mL)

May 6, 2011

Subject: Cytarabine Injection Crystallization in 2 g/ 20 mL (100 mg/mL) vials

Dear Healthcare Professional,

Hospira is bringing to your attention the potential for Cytarabine crystallization in certain lots of Cytarabine Injection (DIN: 02126656); 2 g/ 20 mL (100 mg/mL) product currently on the Canadian market. Cytarabine crystallization has been reported in certain vials of Cytarabine lots outside of Canada. Upon investigation, the crystals were determined to be particles of the active pharmaceutical ingredient. Corrective actions have been taken and the issue has been resolved for future lots which will be available by May 27, 2011 at the latest.

Lots that may demonstrate crystallization include:
X022016AA
X032016AA
X042016AA

The most probable cause for the crystallization from root cause analysis is dried Cytarabine on the filling needles which may enter the vials during manufacturing, subsequently acting as a seed for crystal formation. No adverse events have been reported in connection with the crystallization issue.

Storage conditions for Cytarabine Injection are as follows:

• Protect from light.
• Store the product at controlled room temperature 15°-25°C

As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discoloration, and leakage prior to administration, whenever solution and container permit. 

Upon receipt of the new lot in May, please contact Hospira Customer Service team by phone at 1-866-488-6088, option 3, or by email: contacthospira.ca@hospira.com to return any remaining inventory (X022016AA, X032016AA and X042016AA).

For medical information, contact Hospira Clinical Support Group at 1-866-488-6088, option 4 or e-mail, mail-clinSupport@hospira.com.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse reactions in patients receiving Cytarabine Injection (100 mg/mL) should be reported to Hospira Healthcare Corporation or Health Canada at the following addresses:

We apologize for any inconvenience this action may cause.     

Sincerely,

original signed by

Beryl Chan
Regional Director, Quality and Regulatory Affairs
Hospira Healthcare Corporation