Vagifem® 10: out of specification
Brand(s)
Last updated
Summary
Product
Vagifem® 10
Issue
Health products - Product safety
What to do
Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot |
|---|---|---|---|---|---|
| Vagifem® 10 | Vagifem® 10 | DIN 02325462 | Vaginal Tablet | ESTRADIOL (ESTRADIOL HEMIHYDRATE) 10 MCG | PE78516, RE78561, RE78566, RE78594, RE78796 |
Issue
The dissolution is out of specification in the affected lots.
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: Wholesalers
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Novo Nordisk Canada Inc.
101-2476 Argentia Road,
Mississauga, Ontario
L5N 6M1
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type III
Identification number
RA-77810
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