Cetrotide (Cetrorelix for Injection) - Increased Reconstitution Time for Four Lots of Cetrotide 3mg - For the Public

Starting date:

May 29, 2013

Posting date:

May 31, 2013

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-33849

This is duplicated text of a letter from EMD Serono, A Division of EMD Inc., Canada. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on Cetrotide 3 mg product (Cetrorelix for injection)

May 29, 2013

Dear Patients and Customers:

Subject: Increased Reconstitution time for four lots of Cetrotide^® 3mg product (Cetrorelix for injection)

EMD Serono, a Division of EMD Inc., Canada, in consultation with Health Canada, is advising patients that there is a potential for four lots of Cetrotide^® 3mg product (Lot P00005H, P00006F, P00006P and P00007D) to have an increased reconstitution time longer than the standard 3 minutes: in some instances up to 11 minutes.

Reconstitution time is the time it takes for product in powder form to be fully dissolved in the diluent. The four lots identified were distributed in Canada between October 2011 and March 2013.

• Laboratory testing has found that reconstitution times for some vials of Cetrotide^® 3 mg exceeded 3 minutes.
• After reconstitution the product should not be used if solution appears cloudy, lumpy or discolored. Patients should use the product only if it is a clear solution without particles as indicated in the Product Monograph and package insert.
• Patients should follow the administration information in the package insert and contact their health care professional if they have any concerns about using this product.

An investigation is currently in progress at the manufacturer in Europe to determine root cause of this issue.

Note that Cetrotide^® is also supplied in a 0.25mg/vial format. This 0.25mg/vial format is not affected by this product notice.

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-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected reactions in patients receiving Cetrotide^® 3mg product should be reported to EMD Serono or Health Canada.

EMD Serono, A Division of EMD Inc., Canada

2695 North Sheridan Way, Suite 200

Mississauga ON L5K 2N6

Telephone: 1-888-737-6668 xt.5160, Fax: 905-919-0292

You can report any suspected side effect 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_UVECM@hc-sc.gc.ca

Telephone: 1-800-267-9676

Fax: 613-946-5636

Should you have any questions regarding this matter, please do not hesitate to contact EMD Serono's patient support team at 1-800-387-8479 or Health Canada at 1-800-267-9676: or email: DCVIU_UVECM@hc-sc.gc.ca

Thanks and Kind Regards,

original signed by

Michael Lopez

Manager & Head of Quality Operations

EMD Serono (Canada)

Christina Porter

Manager & Head of Fertility & Endocrinology Business Unit

EMD Serono (Canada)