Health Product InfoWatch: March 2026

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• Health Products and Food Branch
• Marketed Health Products Directorate
• Health Product InfoWatch Editorial Team
• ISSN: 2368-8025
• Cat.: H167-1E-PDF
• Pub.: 250000

Contents

• Monthly recap of health product safety information
  • Bicillin L-A
  • Bortezomib
  • Cefazolin for injection USP
  • MAR-Amlodipine
  • Seasonique and Seasonale
• New health product safety information
  • Product monograph update
  • Stivarga (regorafenib)
  • Notice of market authorization with conditions
  • Voxzogo (vosoritide for injection): Authorization with conditions
• Scope
• Reporting Adverse Reactions
• Helpful links
• Contact us

Monthly recap of health product safety information

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in February 2026 by Health Canada.

Bicillin L-A

Given the medical necessity of Bicillin L-A 1 200 000 IU / 2 mL and the need to maintain continuity of supply in Canada, Health Canada has authorized the exceptional, temporary importation and sale of Portuguese-authorized Lentocilin S 1200; 1 200 000 IU / 4 mL, to mitigate the shortage. Lentocilin S 1200 has the same active ingredient, strength and route of administration as Bicillin L-A; however, there are differences in the formulation, dosage form, reconstitution requirement and presentation between these products.

Health Product Risk Communication: Bicillin L-A

Bortezomib

This safety review evaluated the risk of drug reaction with eosinophilia and systemic symptoms (DRESS) associated with bortezomib-containing products. Health Canada’s safety review found a possible link. Health Canada will work with the manufacturers to update the product safety information in the Canadian product monographs for all bortezomib-containing products to include this risk.

Summary Safety Review: Bortezomib

Cefazolin for injection USP

An affected lot of Cefazolin for injection has been recalled as the vials may be underfilled.

Type I drug recall: Cefazolin for injection USP

MAR-Amlodipine

Two lots of MAR-Amlodipine 5mg tablets have been recalled as some bottles may contain tablet(s) of midodrine 2.5mg. Substituting amlodipine (5 mg) with midodrine (2.5 mg) can lead to serious side effects such as a dangerous increase in blood pressure, dizziness, fainting and organ damage.

Advisory: MAR-Amlodipine
Type I drug recall: MAR-Amlodipine

Seasonique and Seasonale

Two lots of Seasonique (0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol tablets, and 0.01 mg ethinyl estradiol tablets) and 1 lot of Seasonale (0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol tablets) prescription birth control pills have been recalled as a precautionary measure, after receiving a complaint that a Seasonique package was missing an entire blister card of pills. This may increase the risk of unwanted pregnancy if someone were to miss taking them.

Advisory: Seasonique and Seasonale
Type I drug recall: Seasonique and Seasonale

New health product safety information

The following topics have been selected to raise awareness and encourage reporting of adverse reactions.

Product monograph update

The following safety labelling update, which was recently made to the Canadian product monograph, has been included for your awareness. A complete list of safety labelling updates for pharmaceuticals is available on Health Canada's Product monograph brand safety updates page. Canadian product monographs can be accessed through Health Canada's Drug Product Database.

Stivarga (regorafenib)

The Adverse Reactions (Post-Market Adverse Reactions) and Patient Medication Information sections of the Canadian product monograph for Stivarga have been updated Footnote with the risk of *thrombotic microangiopathy.**

Key messages for healthcare professionals: Footnote 1

• Thrombotic microangiopathy (TMA) (including cases identified as thrombotic thrombocytopenic purpura and renal-limited TMA), has been reported in post-marketing experience in association with the use of Stivarga.
• Stivarga therapy should be discontinued if TMA is diagnosed, and prompt treatment is required.
• Reversal of the effects of TMA has been observed after Stivarga therapy was discontinued.

Notice of market authorization with conditions

A Notice of Compliance with Conditions (NOC/c) is a form of market authorization with conditions granted to a product on the basis of promising **** evidence of clinical effectiveness following review of the submission by Health Canada. Communicating an NOC/c is intended to raise awareness on the details of the drug and the type of authorization granted.

Healthcare professionals are encouraged to report to Health Canada any adverse reactions suspected of being associated with marketed health products, including drugs authorized under the NOC/c policy.

The content of these notices reflects current information at the time of publication. Conditions associated with the NOC/c will remain until they have been fulfilled and authorized by Health Canada. For the most up-to-date information, consult Health Canada's NOC database.

Voxzogo (vosoritide for injection): Authorization with conditions

Health Canada has issued a Notice of Compliance, under the NOC/c policy, for Voxzogo (vosoritide for injection), lyophilized powder for reconstitution for subcutaneous use, 0.4mg, 0.56 mg and 1.2 mg single-use vials. Voxzogo is indicated to increase linear growth in patients with achondroplasia who are 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing. Patients and caregivers should be advised of the conditional market authorization for this indication.

For the complete prescribing information and information available for patients/caregivers, please consult the Voxzogo Canadian product monograph. The product monograph can be accessed through Health Canada’s Drug Product Database, the BioMarin Pharmaceutical Inc. website or by contacting BioMarin at 1-800-983-4587. Contact the company for a copy of any references, attachments or enclosures.

Scope

This monthly publication is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices and natural health products. It provides a summary of key health product safety information published in the previous month by Health Canada, as well as a selection of new health product safety information meant to raise awareness. New information contained in this issue is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.

Reporting Adverse Reactions

Canada Vigilance Program
Telephone: 1-866-234-2345
Fax or mail: Form available on MedEffect Canada

For more information on how to report an adverse reaction, visit the Adverse Reaction and Medical Device Problem Reporting page.

Helpful links

• MedEffect™ Canada
• Recalls and Safety Alerts Database
• New Safety and Effectiveness Reviews
• Canada Vigilance Adverse Reaction Online Database
• Glossary of Fields in the Canada Vigilance Adverse Reaction Online Database
• Drug Product Database
• Medical Devices Active Licence Listing
• Licensed Natural Health Products Database
• The Drug and Health Product Portal
• Drug Shortages Canada
• Medical Device Shortages
• COVID-19 Vaccines and Treatments Portal

Contact us

Your comments are important to us. Let us know what you think by reaching us at: infowatch-infovigilance@hc-sc.gc.ca

Health Product InfoWatch Editorial Team
Marketed Health Products Directorate
Health Canada
Address Locator 1906C
Ottawa ON K1A 0K9

Reference

Footnote 1 Stivarga (regorafenib) [product monograph]. Mississauga (ON): Bayer Inc.; 2025.

Return to footnote 1 referrer

Footnote

Footnote * This update reflects the outcome of Health Canada’s safety review, as summarized in the published summary safety review.

Return to footnote * referrer

Page details

2026-03-26