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CIPROFLOXACIN INJECTION - Voluntary Recall - Notice to Hospitals

Starting date:
June 4, 2010
Posting date:
June 9, 2010
Type of communication:
Notice to Hospitals
Source of recall:
Health Canada
Healthcare Professionals
Identification number:

This is duplicated text of a letter from BioSyent Pharma 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 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.

  • All lots of Ciprofloxacin Injection 2 mg/mL are being recalled to the user level as a precautionary measure.
  • Ciprofloxacin Injection 2 mg/mL Intravenous infusion 100 mL and 200 mL bags were manufactured by Claris Lifesciences Limited ("Claris") and therefore these products will bear both the BioSyent Pharma Inc. and Claris Lifesciences Limited names on the product and packaging.

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 2 mg/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

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

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™ 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)
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.