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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:
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-AmmarRegional Director, Commercial Quality
Hospira Healthcare Corporation