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Health professional risk communication

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

Starting date:
May 29, 2013
Posting date:
May 31, 2013
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-33847

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

Health Canada Endorsed Important Safety Information on Cetrotide 3mg (Cetrorelix for Injection)

May 29, 2013

Dear Health Care Professional:

Subject: Cetrotide® 3mg (Cetrorelix for Injection): DIN 02247767

Notification: Reconstitution time may exceed 3 minutes for four lots distributed in Canada: Lot P00005H, P00006F, P00006P and P00007D.

EMD Serono, A Division of EMD Inc., Canada in consultation with Health Canada, is advising you that there is a potential for vials in four identified lots of Cetrotide® 3mg product, that were distributed in Canada during the period October 2011 - March 2013, to have a reconstitution time longer than 3 minutes. Cetrotide® is a gonadotropin-releasing hormone antagonist indicated for prevention of premature ovulation in patients undergoing controlled ovarian stimulation.

The reconstitution time should not normally be more than three minutes, but during laboratory re-testing after batch release, in some vials from the identified batches, reconstitution times were found to exceed three minutes.  In some cases the reconstitution times were up to eleven minutes.

  • Laboratory testing has found that reconstitution times for some vials of Cetrotide® 3 mg exceeded 3 minutes.
  • Do not use if solution appears cloudy, lumpy or discoloured. Patients can use the product only after reconstitution is completed (clear solution with no particles as indicated in the Product Monograph and package insert).
  • Health care professionals should review reconstitution procedures with their patients and inform them that times may be longer than previously experienced.
  • Patients should be advised to follow the administration information in the patient package insert and contact their health care professionals if they have any concerns about using this product.

The investigation is in progress at the product manufacturer in Europe to determine root cause.  Note that Cetrotide® is also supplied in a 0.25mg/vial format (DIN 02247766). This 0.25mg/vial format is not affected by the above mentioned notice.

The involved Cetrotide® 3mg lots (Lot P00005H, Lot P00006F, Lot P00006P and Lot P00007D) were imported into Canada in Oct 2011 to Mar 2013 and were released to the market. There is no indication that market action is required for Cetrotide® 3mg product. Disposition is as follows:

  1. Lot P00005H: 972 units
    Received: 19 Oct 2011  |  Released: 21 Oct 2011  |  Expiry Date: 31 Mar 2013
    (All units distributed to Canadian market.  This Lot completed normal expiry on 31 Mar 2013).
  2. Lot P00006F: 387 units
    Received: 18 Apr 2012  |  Released: 02 May 2012  |  Expiry Date: 30 Nov 2013
    (All units distributed to the Canadian market).
  3. Lot P00006P: 382 units
    Received: 30 Oct 2012  |  Released: 09 Nov 2012  |  Expiry Date: 30 Nov 2013
    (All units distributed to the Canadian market).
  4. Lot P00007D:  582 units
    Received: 18 Mar 2013  |  Released: 22 Mar 2013  |  Expiry Date: 30 Jun 2014
    (All units released and will be made available to the Canadian market by end May 2013).

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
Tel: 1 888 737 6668 ´5160
Fax: 905 919 0292
E-mail: drugsafetycanada@merckserono.net

To correct your mailing address or fax number, contact EMD Serono, A Division of EMD Inc., Canada.

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

For other health product inquiries related to this communication, please contact Health Canada at:
Health Product and Food Branch Inspectorate
E-mail: DCVIU_UVECM@hc-sc.gc.ca
Tel: 1-800-267-9676
Fax: 613-946-5636

Should you have any questions regarding this notification for Cetrotide® 3mg product, please call the EMD Serono Medical Information/Drug Safety Department at 1-888-737-6668 x5160 or our Customer Service department at 1 800 387 9749.

original signed by

Michael Lopez
Manager& Head of Quality Operations

Peter Grosser, Ph.D.
Director, Scientific Affairs