Public recall detail

Remifentanil hydrochloride for injection; Out of specification (Assay & Impurity)

2026-06-26

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Health products Health product recall
Quick summary

Quick summary: Remifentanil hydrochloride for injection; Out of specification (Assay & Impurity). Reason: Health product recall. Category: Health products. Date: 2026-06-26.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Remifentanil hydrochloride for injection; Out of specification (Assay & Impurity). Reason: Health product recall. Category: Health products. Date: 2026-06-26.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSterimax Inc.
ProductRemifentanil hydrochloride for injection 1 mg/vial
IssueHealth products - Product quality
Recall classType II
IdentificationRA-82254

Affected products

BrandSterimax Inc.
ProductRemifentanil hydrochloride for injection
DIN / NPN / authorizationDIN 02366460
Dosage formPowder for solution
StrengthRemifentanil hydrochloride 1 mg/vial
Lot243101O, 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 official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Drugs
CompaniesSterimax Inc.2770 Portland DriveOakville Ontario L6H 6R4 Canada
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82254
Background{}
CompaniesSterimax Inc.2770 Portland DriveOakville Ontario L6H 6R4 Canada
AudiencesGeneral public Healthcare Industry
Source updated2026-06-26

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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