Dotarem Injection: Product Sterility
Last updated
Summary
Product
Dotarem Injection
Issue
Health products - Product safety
What to do
See instructions below.
Affected products
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot |
|---|---|---|---|---|---|
Dotarem |
Dotarem Injection |
DIN 02459329 |
Solution |
Gadoterate Meglumine 376.9 mg/ml, equivalent to 0.5 mmol/ml |
20GD087B02 |
Issue
| Product sterility may be compromised in the affected lot due to the possibility of defects in the vial. |
What you should do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Additional information
Background
Depth of recall: Healthcare Establishments
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
|
Methapharm Inc. 81 Sinclair Boulevard, Brantford, Ontario, N3S 7X6 |
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type I
Identification number
RA-63625
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