Health Product InfoWatch: May 2025

Contents

• Monthly recap of health product safety information
  • Fluoxetine
  • JAMP Valproic Acid Oral Solution
  • Lidocaine Hydrochloride and Epinephrine Injection USP
  • Unauthorized Health Products
• New health product safety information
  • Notice of market authorization with conditions
    • Tagrisso (osimertinib mesylate): 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 April 2025 by Health Canada.

Fluoxetine

Affected lots of fluoxetine have been recalled as they exceed the interim acceptable intake limit for N-nitroso-fluoxetine.

Type 1 drug recall: PMS-Fluoxetine
Type 1 drug recall: PRO-Fluoxetine
Type 1 drug recall: RIVA-Fluoxetine

JAMP Valproic Acid Oral Solution

JAMP Pharma Corporation recalled 3 lots of JAMP Valproic Acid Oral Solution after receiving complaints of large solid crystals that do not dissolve when the bottles are shaken, and that are difficult to break apart. The company has indicated that the crystals are sucrose. The crystals may pose a choking hazard, especially in young children or people with difficulty swallowing.

Advisory: JAMP Valproic Acid Oral Solution

Lidocaine Hydrochloride and Epinephrine Injection USP

A lot of Lidocaine Hydrochloride and Epinephrine Injection USP has been recalled as it may contain particles.

Type 1 drug recall: Lidocaine Hydrochloride and Epinephrine Injection USP

Unauthorized Health Products

Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online that may pose serious health risks.

Advisory: Fake Cialis seized from South China Herbs Market Inc. in Toronto
Advisory: Unauthorized injectable peptide drugs seized from Optimum Wellness Centre in Calgary
Advisory: Unauthorized injectable peptide drugs sold by Prime Research
Advisory: Unauthorized sexual enhancement products
Advisory: Unauthorized workout supplements

New health product safety information

The following topic has been selected to raise awareness and encourage reporting of adverse reactions.

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 a 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.

Tagrisso (osimertinib mesylate): Authorization with conditions

Health Canada has issued a Notice of Compliance, under the Notice of Compliance with Conditions policy, for a new indication for Tagrisso* (osimertinib mesylate), 40 mg and 80 mg oral tablets. The new indication for Tagrisso is for the treatment of patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum based chemoradiation therapy. Patients 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 Tagrisso Canadian product monograph. The product monograph can be accessed through Health Canada’s Drug Product Database, the AstraZeneca website or by contacting AstraZeneca at 1-800-668-6000. Contact the company for a copy of any references, attachments or enclosures.

*Tagrisso’s updated product monograph with this NOC/c indication is dated April 2025.

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^TM Canada
• Recalls and Safety Alerts Database
• New Safety and Effectiveness Reviews
• 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