Certain vials of fertility drug Cetrotide recalled because of potential contamination
- Starting date:
- July 4, 2020
- Type of communication:
- Source of recall:
- Health Canada
- Suspected quality concern
- General Public
- Identification number:
- 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.
- Products affected
- What you should do
- Who is affected
- Related AWRs
- Media enquiries
- Public enquiries
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.
|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.
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- Date modified: