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Health professional risk communication

Cytarabine Injection 2g / 20mL - Missing or Partially Detached Label - Notice to Hospitals

Starting date:
July 30, 2014
Posting date:
July 30, 2014
Type of communication:
Notice to Hospitals
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Labelling and Packaging, Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-40821

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

Notice about Health Canada advisories

NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on Cytarabine Injection 2g / 20mL

July 30, 2014

Dear Healthcare Professional and Director of Pharmacy,

Please distribute to the relevant Departments (Pharmacy, Emergency Medicine, Paediatrics, Geriatrics, Internal Medicine, Nursing, Intensive Care, Oncology, Oncology Clinics and/or other Departments as required), other involved professional staff, and post this NOTICE in all relevant areas of your institution.

Subject: Missing or partially detached label for vials of Hospira Cytarabine Injection 2g / 20mL (DIN 02126656), lot A012016AA

Hospira Healthcare Corporation, in consultation with Health Canada, is issuing this Important Safety Notice to alert Healthcare Professionals that some vials of one lot (A012016AA) of Cytarabine Injection 2g / 20mL may have a missing label on the vial or a partially detached label. There have been customer reports where labels of vials from lot A012016AA were missing or slightly lifted.

  • There is a potential risk of medication error and patient harm if an unlabelled product is administered to a patient. 
  • Healthcare professionals should NOT use any vial of Cytarabine Injection 2g / 20mL that is unlabelled or has a partially detached label. Vials with missing or partially detached labels should be quarantined and returned to Hospira Healthcare Corporation.
  • Healthcare Professionals are advised to check their stock immediately and verify that the vials are properly labelled.

To return your quarantined product, please contact Hospira Healthcare Corporation at: 1-866-488-6088 Option 3, contacthospira.ca@hospira.com. A Return Goods Authorization (RGA) number will be issued to facilitate the return of your products.

The root cause is currently being investigated by Hospira Healthcare Corporation. To date, there have been no adverse events associated with this issue.

The product impacted is:

Description
Cytarabine Injection 2g / 20mL
 
DIN
02126656
 
Lot
A012016AA
 
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 2g / 20mL should continue to be reported to Hospira Healthcare Corporation or Health Canada:

Hospira Healthcare Corporation
1111 Dr.-Fredrerik-Philips, Suite 600
Saint-Laurent (Quebec) H4M 2X6

To report an Adverse Reaction, consumers and health professionals may call toll free:

Tel: 1-866-488-6088 Option 6
Fax: 1-877-906-0208
Email: ProductcomplaintsCA@hospira.com

To correct your mailing address or fax number, contact Hospira Healthcare Corporation.

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, please contact Health Canada at:
Health and Product and Food Branch Inspectorate
E-mail: DCVIU_ UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

Sincerely,

original signed by

Rania Al-Ammar
Regional Director, Commercial Quality
Hospira Healthcare Corporation