Certain vials of fertility drug Cetrotide recalled because of potential contamination

Starting date:
July 4, 2020
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Suspected quality concern
Audience:
General Public
Identification number:
RA-73487

Last updated:

Summary

  • Product: Cetrotide 0.25mg
  • Issue: One lot of Cetrotide 0.25mg is being recalled because some vials may have missing stoppers, which could make the product unsterile.
  • What to do: Check the lot number on your product or contact your pharmacist to determine whether your product is subject to this recall. If you have a recalled product, do not take the medication. Contact your healthcare provider as soon as possible to obtain a replacement and avoid any interruption to your treatment.

Issue

Health Canada is advising Canadians that EMD Serono, a Division of EMD Inc. Canada, is recalling one lot of Cetrotide 0.25mg because some vials may have missing stoppers, which could make the product unsterile.

Cetrotide is used in fertility treatment to help women get pregnant by stopping the body from releasing an egg from the ovary (ovulation) early so that it can be released at the best time for pregnancy to occur.

An unsterile product could introduce microorganisms when injected under the patient’s skin. This may result in a local infection, such as an abscess, or an infection of the skin and deeper underlying tissues (cellulitis). Some infections can be serious if they spread to the blood, bones, heart or other areas of the body.

In addition, some of the contents of the vial may have spilled out because of the missing stopper, so the patient may not receive the proper dose and the drug would not be as effective.

Health Canada will monitor the company’s recall and inform Canadians if new safety information becomes available.

Products affected

Company Product Name DIN Strength Lot Expiry
EMD Serono, a Division of EMD Inc. Canada Cetrotide 02247766 0.25mg 8J025C 09/2020

What you should do

  • Check the lot number on your product or contact your pharmacist to determine whether your product is subject to this recall.
  • If you have a recalled product, do not take the medication and contact your healthcare provider to obtain a replacement product.
  • If you become aware of any unusual symptoms or side effects that may be associated with this product, contact your healthcare provider.
  • Report any health product-related adverse reactions or complaints to Health Canada.
  • If you have any questions regarding the recall, contact EMD Serono, a Division of EMD Inc. Canada: 1-800-387-8479

Who is affected

Patients who are taking Cetrotide 0.25mg.

Cetrotide (2020-07-03)

2020-07-03 | Health products

Recall

Media enquiries

Health Canada
613-957-2983
hc.media.sc@canada.ca

Public enquiries

613-957-2991
1-866-225-0709
hcinfo.infosc@canada.ca

Images

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