Neupogen vials; Out of specification (Stability)
Brand(s)
Last updated
Summary
Product
Neupogen 300 mcg/mL (480 mcg /1.6 mL) vials
Issue
Health products - Product quality
What to do
Consult your health care professional if you have any health concerns.
Affected products
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot numbers |
|---|---|---|---|---|---|
Amgen Canada |
Neupogen 300 mcg/mL (480 mcg /1.6 mL) vials |
DIN 019688017 |
Solution |
Filgrastim 300 mcg/mL (480 mcg/1.6 mL) |
1164588, 1172461, 1157891, 1152785 (1164634, 1157892) |
Issue
The stability may be 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 - Biologic or vaccine
Companies
Amgen Canada Inc.
6775 Financial Drive, Unit 300
Mississauga ON L5N 0A4
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type III
Identification number
RA-77190
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