Remifentanil hydrochloride for injection; Out of specification (Assay & Impurity)
Brand(s)
Last updated
Summary
Product
Remifentanil hydrochloride for injection 1 mg/vial
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 Number |
|---|---|---|---|---|---|
| Sterimax Inc. | Remifentanil hydrochloride for injection | DIN 02366460 | Powder for solution | Remifentanil hydrochloride 1 mg/vial | 243101O, 243110D, 253101D |
Issue
The assay and impurity 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
Sterimax Inc.
2770 Portland Drive
Oakville Ontario L6H 6R4 Canada
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-82254
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