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Cefazolin for Injection USP 1g - Potential for Longer Reconstitution Time and Precipitation of the Reconstituted Solution - Notice to Hospitals

Starting date:
April 9, 2014
Posting date:
April 10, 2014
Type of communication:
Notice to Hospitals
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-38991

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 Cefazolin for Injection USP 1g

April 9, 2014

Dear Healthcare Professional,

Please distribute to the relevant Departments (Surgery, Emergency, Pharmacy, Paediatrics, Anaesthesia/PACU, Geriatrics, Internal Medicine, Nursing, Intensive Care, Day hospital, Cardiology, Orthopaedics, Urology, Labor-Deliver/Post Partum, Oncology, Burn Units), Homecare Programmes, Clinics and other involved professional staff and post this NOTICE in all relevant areas of your institution.

Subject: Potential for longer reconstitution time1 and precipitation of the reconstituted solution of Cefazolin for Injection USP 1g (DIN 02297205)

Hospira, the manufacturer of Cefazolin for Injection USP 1g, distributed in Canada by Apotex Inc,  in consultation with Health Canada, is issuing this Important Safety Information Notice to alert Healthcare Professionals that some vials may exhibit longer reconstitution time than normal (typically the reconstitution time should not exceed 180 seconds). Additionally, complaints of the formation of cloudy solution upon reconstitution have been received. The cloudiness of the solution represents precipitation of the drug in solution.

  • Some vials may exhibit longer reconstitution time than normal (typically the reconstitution time should not exceed 180 seconds). Precipitation and cloudiness of the reconstituted solution have been observed in some vials.
  • There is a potential risk that precipitated or particulate matter introduced into the blood stream may result in patient injury, such as local inflammation, phlebitis, allergic response and/or an embolic event.
  • Healthcare professionals are advised to ensure complete reconstitution and carefully inspect the reconstituted solution for cloudiness and particulate matter prior to administration.
  • Do not administer if precipitation, particulate matter or cloudy solution is observed upon reconstitution. Vials that exhibit cloudiness, precipitation or particulate matter should be discarded.

The issue has been attributed to higher water content in the affected vials. The root cause of the high water content is currently being investigated by Hospira.

The product impacted is:

Description Cefazolin for Injection USP 1g

DIN 02297205

Appropriately reconstituted Cefazolin for Injection 1g (intravenous, intramuscular) solutions should appear as a clear solution that may range in colour from pale yellow to yellow. It is indicated in the treatment of the following infections due to susceptible organisms: respiratory tract infections, urinary tract infections, skin and skin structure infections, biliary tract infections, bone and joint infections, genital infections, septicemia, endocarditis, perioperative prophylaxis.

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 Cefazolin for Injection 1g should continue to be reported to Apotex Inc., our distributor, or Health Canada:

Apotex Inc.
150 Signet Drive,
Toronto (Ontario) M9L 1T9

To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 1-800-667-4708
Fax: 1-416-401-3819
Email: Drugsafety@apotex.com

To correct your mailing address or fax number, contact Apotex 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, 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

Reference:

1. Reconstitution time: The reconstitution time is the time required for the complete dissolution of the drug powder into the diluent.