Health Product InfoWatch: August 2025

Contents

• Monthly recap of health product safety information
  • Epinephrine injection USP, Sodium Bicarbonate injection USP and Dextrose injection USP
  • Mylan-Cinacalcet
  • NRA-Amlodipine
  • PMS-Methylphenidate CR
  • RIVA-Fluoxetine
  • Taro-Doxorubicin Liposomal
  • Unauthorized Health Products
• New health product safety information
  • Medication error alert
    • Brand name confusion between Diclectin and Dicetel
  • Product monograph updates
    • Ilaris (canakinumab)
    • Oral anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban, warfarin)
  • Notice of market authorization with conditions
• Braftovi (encorafenib): 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 July 2025 by Health Canada.

Epinephrine injection USP, Sodium Bicarbonate injection USP and Dextrose injection USP

Affected lots of Epinephrine injection USP, Sodium Bicarbonate injection USP and Dextrose injection USP were recalled as they may contain the presence of microbiological contamination.

Type I drug recall: Epinephrine injection USP, Sodium Bicarbonate injection USP and Dextrose injection USP

Mylan-Cinacalcet

Affected lots of Mylan-Cinacalcet have been recalled as they exceed the established acceptable intake limit for N-nitroso-cinacalcet.

Type I drug recall: Mylan-Cinacalcet

NRA-Amlodipine

One lot of NRA-Amlodipine 5 mg tablets has been recalled because some bottles may contain the wrong tablets, which have been identified as metoprolol succinate prolonged-release 12.5 mg tablets. Substituting amlodipine (5 mg) with metoprolol (12.5 mg) can lead to serious adverse reactions.

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

PMS-Methylphenidate CR

One lot of PMS-Methylphenidate CR 10 mg capsules has been recalled as it exceeds the acceptable intake limit for N-nitroso-methylphenidate.

Type I drug recall: PMS-Methylphenidate CR

RIVA-Fluoxetine

Affected lots of RIVA-Fluoxetine 10 mg capsules have been recalled as they may exceed the interim acceptable intake limit for N-nitroso-fluoxetine.

Type I drug recall: RIVA-Fluoxetine

Taro-Doxorubicin Liposomal

One lot of Taro-Doxorubicin Liposomal has been recalled as it may contain the presence of particulate matter.

Type I drug recall: Taro-Doxorubicin Liposomal

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: Unauthorized Natrol DHEA Mood & Stress health product sold by Retail Revolt
Advisory: Unauthorized sexual enhancement products
Advisory: Unauthorized workout supplements

New health product safety information

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

Medication error alert

Brand name confusion between Diclectin and Dicetel

Diclectin and Dicetel are both authorized as prescription drugs in Canada. They are 2 distinct medications with key differences in active ingredients, indication, formulation and dosage schedule.

Diclectin is a combination of doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6). It is indicated for the management of nausea and vomiting in pregnancy.^{Footnote 1} Dicetel (pinaverium bromide) is a calcium antagonist that induces relaxation of the gastrointestinal and biliary tracts. It is indicated for the treatment and relief of symptoms associated with irritable bowel syndrome and functional disorders of the biliary tract.^{Footnote 2} Both products have been on the Canadian market for over 20 years. While both products are available in a tablet form, Diclectin comes as delayed-release tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, whereas Dicetel is available as film-coated tablets containing 50 mg or 100 mg pinaverium bromide. Diclectin is usually taken as 1 tablet in the morning, 1 tablet mid-afternoon, and 2 tablets at bedtime while Dicetel is usually taken as 50 mg or 100 mg 3 times daily.

In 2014, the Institute for Safe Medication Practices Canada published a case of medication error caused by brand name confusion between Diclectin and Dicetel. In this case, a pregnant patient was prescribed Diclectin but was inadvertently dispensed Dicetel.^{Footnote 3} Such medication errors continue to occur with these products due to the similarity of their brand names, despite differences in tablet strength and dosing regimens.

Health Canada recently received a domestic report involving a pregnant patient who was erroneously prescribed Dicetel 100 mg instead of Diclectin for the treatment of pregnancy-related nausea. The prescription was filled at a community pharmacy, and the patient reportedly took the incorrect medication for 2 weeks. According to the report, the patient did not experience any adverse reactions from the treatment, although the nausea remained uncontrolled. It is unknown whether the error caused harm to the fetus.

Healthcare professionals are reminded to be vigilant of the look-alike/sound-alike risk associated with the brand names of Diclectin and Dicetel. Healthcare professionals are also encouraged to report medication errors caused by brand name confusion between these two products to the Canadian Medication Incident Reporting and Prevention System (CMIRPS), a program in which Health Canada participates.

Product monograph updates

The following safety labelling updates, which were recently made to the Canadian product monographs, have 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.

Ilaris (canakinumab)

The Warnings and Precautions and Patient Medication Information sections of the Canadian product monograph for Ilaris have been updated with the risk of drug reaction with eosinophilia and systemic symptoms (DRESS).

Oral anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban, warfarin)

The Warnings and Precautions, Adverse Reactions (Post-Market Adverse Reactions) and Patient Medication Information sections of the Canadian product monographs (CPMs) for oral anticoagulants^{Footnote *} containing apixaban, dabigatran, edoxaban, rivaroxaban and warfarin are being updated with the risk of anticoagulant-related nephropathy.

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.

Braftovi (encorafenib): Authorization with conditions

Health Canada has issued a Notice of Compliance, under the Notice of Compliance with Conditions policy, for a new indication for Braftovi^{Footnote **} (encorafenib), 75 mg oral capsules. The new indication for Braftovi is in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a validated test. 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 Braftovi Canadian product monograph. The product monograph can be accessed through Health Canada's Drug Product Database, the Pfizer website or by contacting Pfizer at 1-800-463-6001. 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^TM 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