Review Determines ImmuCyst Lot Can be Released for Use

Starting date:

September 14, 2012

Posting date:

September 14, 2012

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-15054

• Media enquiries
• Public enquiries

As a follow-up to our July 11, 2012 communication on the cancer bladder treatment ImmuCyst, Health Canada has cleared for release one lot of the product that was being held due to problems in the facility where it was produced. The lot contains 1,500 doses for Canadian patients across Canada.

Health Canada has authorized the release of lot #C4040AA after Departmental experts' thorough review determined that there is no direct evidence of microbial contamination.

There have been no reports of infection that might be caused by contamination. In the post-marketing surveillance of ImmuCyst, patients who receive ImmuCyst are under active medical supervision and as such, any possible health impacts related to the manufacturing problems would be identified by their health care practitioner.

Sanofi Pasteur has informed Health Canada of its decision to temporarily suspend manufacturing in order to renovate the facility where ImmuCyst is manufactured to improve the quality of the environment of the manufacturing facility. Patients and Canadian health care practitioners are advised to contact Sanofi Pasteur (1-800-268-4171) for any updates on product availability.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709