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Health professional risk communication

ENDOMETRIN (100 mg Progesterone Effervescent Vaginal Tablets) - Voluntary Recall of Two Lots Due to a Possible Lack of Therapeutic Efficacy - For Health Professionals

Starting date:
November 26, 2013
Posting date:
November 26, 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-36951

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

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on Endometrin

November 25, 2013

Dear Health Care Professional,

Subject:  ENDOMETRIN® (100 mg Progesterone Effervescent Vaginal Tablets) Voluntary Recall of lots: 0804.209A-1 and 0804.219A-1
Reason: Discolouration of blister packaging and tablets which could potentially be associated with lack of therapeutic efficacy

Ferring Inc. Canada, in consultation with Health Canada, would like to inform Health Care Professionals of a voluntary recall on a precautionary basis of two (2) lots of ENDOMETRIN. The recall is due to a possible discolouration of blister packaging and tablets as a result of an intermittent equipment malfunction at the packaging facility.

ENDOMETRIN is indicated for progesterone supplementation in women undergoing in vitro fertilization.

The discolouration of tablets occurs intermittently due to a problem during the packaging process which may have caused degradation of the active substance (progesterone) within the tablet. Reports of discoloured tablets and blister packaging have been received from other countries. To date, Ferring Canada has not received any complaints of discolouration of tablets or blister packaging or reports of lack of efficacy with the Canadian recalled lots.

  • A problem experienced during the packaging of ENDOMETRIN tablets might result in a sub-optimal dose that could lead to decreased or lack of therapeutic efficacy.
  • As a precautionary measure, Ferring Canada has begun the voluntary recall on the two (2) lots affected from the wholesalers and fertility clinics.
  • Currently ENDOMETRIN is unavailable in Canada. Therefore, we suggest Health Care Professionals use an alternative Luteal Phase Support medication as indicated. Projected re-stocking date is December 9th, 2013.

Updates on the resupply can be found on the drug shortages website. If you have not received a recall notice or are uncertain as to what the procedure is, please call Ferring for assistance at 1-866-384-1314 (Medical Information) or Quality Assurance at 1-800-263-4057 on how to return the product.

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 case of serious or unexpected adverse reactions and reports of unusual lack of efficacy in patients receiving ENDOMETRIN or reports of discoloration of tablets or blister packaging should be reported to Ferring Inc. Medical Information at 1-866-384-1314 or Health Canada.

Ferring Inc.
200 Yorkland Boulevard, Suite 500
Toronto, ON
M2J 5C1

To correct your mailing address or fax number, contact Ferring Inc.

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
     
  • 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: 1-800-267-9675
Fax: 1-613-946-563

Sincerely yours,

original signed by

Hitesh Tailor B.Sc. Pharm, R.Ph
Medical Advisor Fertility Reproductive Health
Ferring Inc., Canada