CIPROFLOXACIN INJECTION - Voluntary Recall - Notice to Hospitals

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Contact: Therapeutic Products Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from BioSyent Pharma Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice to Hospitals
Health Canada Endorsed Important Safety Information on CIPROFLOXACIN INJECTION 2 mg/mL (Intravenous Infusion) DIN 02301296

June 4, 2010

To: Hospital Chief of Medical Staff

Please distribute to relevant Departments of Surgery, Emergency Medicine, Pharmacy, Paediatrics, Anaesthesia, Geriatrics, Internal Medicine, Nursing, Dentistry, Intensive Care and/or other Departments as required, and other involved professional staff and post this Notice in your institution.

Subject: Voluntary recall of CIPROFLOXACIN INJECTION 2 mg/mL (Intravenous Infusion) 100 mL bag (UPC 00891339001048) and/or 200 mL bag (UPC 00891339001055) DIN 02301296

All lots of the product identified above, manufactured by Claris Lifesciences Limited ("Claris") and distributed in Canada by Biosyent Pharma Inc., are being voluntarily recalled as a precautionary measure against possible contamination. This precautionary recall is being undertaken due to complaints in the United States about floating matter in intravenous bags of certain other sterile injectable products manufactured by Claris which have subsequently been recalled. Claris has voluntarily extended this recall to include Ciprofloxacin Injection in the United States and similarly, Biosyent Pharma Inc has initiated a recall in Canada.

There are currently no reports in Canada of any adverse reactions or adverse events as a result of the administration of Ciprofloxacin Injection to any patient.

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 CIPROFLOXACIN INJECTION 2mg/mL (DIN 02301296) should be reported to BioSyent Pharma Inc. or Health Canada at the following addresses:

BioSyent Pharma Inc.
2601 Matheson Blvd. East,
Suite 5
Mississauga, Ontario, Canada
L4W 5A8
Tel: 1-888-439-0013
Fax: 905-206-1413
Email: info@biosyent.com

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701E
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
CanadaVigilance@hc-sc.gc.ca

To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789

Postage paid labels, the Canada Vigilance Reporting Forms and the Adverse Reaction Reporting Guidelines can be found on the MedEffect^TM Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

For other health product inquiries related to this communication, please contact Health Canada at:
Health Product and Food Branch Inspectorate (HPFBI)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

To change your mailing address or fax number, contact the Market Authorization Holder (industry).

original signed by

René C. Goehrum
President and CEO
BioSyent Pharma Inc.