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Cefazolin for Injection USP 1 g - May Contain Foreign Particulate Matter and Sterility May be Compromised

Starting date:
February 13, 2015
Posting date:
February 13, 2015
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Suspected quality concern
Audience:
Hospitals
Identification number:
RA-43729

Audiences

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

Key messages

  • Two lots of Cefazolin for Injection USP 1 g (lots 117E006 and 117E005) manufactured by Hospira and distributed in Canada by Apotex Inc., are being voluntarily recalled , due to the potential presence of foreign particulate matter.
  • Inadvertent injection of foreign particulate matter and the potential that sterility has been compromised for these lots could result in risks to health.
  • Vials of the affected lots should not be used and should be returned as outlined in the Recall Notice. Health care professionals are advised to remain vigilant in their follow up of patients that have used the impacted lots.

Issue

This recall is resulting from a complaint received in Canada related to the presence of foreign particulate matter. Presence of foreign particulate matter in vials of the affected lots and the potential for breach of sterility pose the following risks if injected: local inflammation, phlebitis, allergic response and/or embolization in the body, and infection.

Products affected

The product impacted is:
Product Name DIN Strength PKG Format LOT Number EXP. Date
Cefazolin for Injection USP 1 g 02297205 1g 10 mL 117E006 March 2016
117E005

Background information

Cefazolin is indicated in the treatment of the infections caused by susceptible strains of organisms and affecting: the respiratory tract, the urinary tract, the skin and skin structures, the biliary tract, the bones and joints, genitals, as well as for septicemia, endocarditis, perioperative prophylaxis. Hospira has initiated an investigation to further determine the root cause related to this issue and will implement necessary corrective and preventive actions.

Who is affected

Information for consumers

Consumers should discuss with their health care professional if they need more information.

Information for health care professionals

Please inform health care professionals in your organization of this recall notification. If your institution has distributed this product further, notify your consignees that they may have received the product identified above and ask them to follow the instructions provided in the Recall Notice attached.

Action taken by Health Canada

Health Canada is communicating this important safety information to healthcare professionals through its MedEffect Canada website. Health Canada is also monitoring the recall and the implementation of necessary corrective and preventive actions.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious local inflammation, phlebitis, allergic response and/or embolization in the body or other serious or unexpected infection or side effects in patients receiving Cefazolin for Injection 1g should be reported to Apotex 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, contact Health Canada at:

Health and Product and Food Branch Inspectorate (HPFBI)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

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

For more information

The manufacturer advised Health Canada of the risk associated with this health product, and has recalled the impacted 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.