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Ceftriaxone for Injection 10 g/vial - Recall of Seven Lots Due to Particulate Matter - Notice to Hospitals

Starting date:
September 26, 2014
Posting date:
September 26, 2014
Type of communication:
Notice to Hospitals
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-41575

This is duplicated text of a letter from SteriMax Inc. 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 Ceftriaxone for Injection 10 g/vial

September 26, 2014

Dear HealthCare Professional and Director of Pharmacy,

Please distribute to relevant Departments (Surgery, Emergency Medicine, Pharmacy, Paediatrics, Anaesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care and/or other Departments as required), and admixing centres associated with the preparation of this product for your institution and other involved professional staff and post this NOTICE in all relevant areas of your institution.

Subject: Recall of Seven (7) Lots of Ceftriaxone for Injection, 10 g/vial (Lot Numbers: 4CN1349CA, 4CN1350CA, 4CN1351CA, 4CN1352CA, 4CN1353CA, 4CN1354CA, 4CN1355CA) (DIN 02325632) due to Particulate Matter

SteriMax Inc., the distributor of Ceftriaxone for Injection, 10 g vial (DIN 02325632), in consultation with Health Canada is recalling Lots 4CN1349CA, 4CN1350CA, 4CN1351CA, 4CN1352CA, 4CN1353CA, 4CN1354CA, 4CN1355CA due to the finding of visible particulate matter in some vials of the drug product observed upon reconstitution.

  • There is a risk of the presence of particulate matter in the drug product from these lots upon reconstitution.
  • If infused, particulate matter could potentially lead to patient injury, including local inflammation, phlebitis, allergic response, and/or thrombo-embolism and death
  • SteriMax Inc. is advising all users to immediately locate and remove the affected lots from use. Product from these lots should not be used. Return all affected inventory to the original point of purchase.

Reconstituted Ceftriaxone for Injection 10 g solution should appear as a clear solution. The product is used in pharmacy admixture programs only for subsequent intravenous administration. The product is used in hospitals and it is indicated in the treatment of the following infections due to susceptible organisms: lower respiratory tract infections, urinary tract infections, skin and skin structure infections, bone and joint infections, intra-abdominal infections, meningitis, uncomplicated gonorrhea (cervical/urethral, pharyngeal and rectal).

Please examine your stock immediately to determine if you have any of the recalled product lot numbers on hand. If yes, discontinue use immediately and return the recalled product back to the original point of purchase. SteriMax Inc. is currently investigating the issue and has not received any reports of adverse events for the specified lots.

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 Ceftriaxone for Injection, 10 g should be reported to SteriMax Inc., our distributor, or Health Canada.

SteriMax Inc.
Suite 1 – 2735 Matheson Blvd. E.
Mississauga, ON
L4W 4M8
Tel: 1-800-881-3550
Fax: 905-890-0508
e-mail: NDar@Sterimaxinc.com

To correct your mailing address or fax number, contact SteriMax 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 Products 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

Nazia Dar
Director, Quality

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.