Public Advisory - Accel-Ondansetron ODT, Mint-Betahistine and PMS-Pirfenidone tablets recalled due to data integrity concerns
OTTAWA, ON, June 17, 2025 /CNW/ -
Summary
-- Products: All lots of Accel-Ondansetron ODT (4 mg and 8 mg tablets);
Mint-Betahistine (8 mg, 16 mg and 24 mg tablets); PMS-Pirfenidone (267
mg and 801 mg tablets)
-- Issue: Health products - Product safety
-- What to do: Return the affected products to your local pharmacy for a
replacement, and for proper disposal. If you are unsure whether your
product is affected, check with your pharmacy. Consult a health care
professional if you have used the affected product and you have health
concerns. *See June 17, 2025 update for new information on two product
lots.
Affected products
Product DIN Lot Expiry
Accel-Ondansetron ODT 4 mg tablets 02535319 CDX00123 09-2026
Accel-Ondansetron ODT 8 mg tablets 02535327 CEA00123 09-2026
Mint-Betahistine 8 mg tablets 02538121 2330704 2430152 07-2025
01-2026
Mint-Betahistine 16 mg tablets 02538148 2330705 07-2025
2330945 10-2025
2330946 10-2025
2330947 10-2025
2430153 01-2026
Mint-Betahistine 24 mg tablets 02538156 2330706A 07-2025
2430154 01-2026
PMS-Pirfenidone 267 mg tablets 02531526
E0800A 11-2024
E0800C
E0800E
E0800F
PMS-Pirfenidone 801 mg tablets 02531534
E0802A 12-2024
E0802C
Issue
UPDATE: June 17, 2025 - Accel Pharma can resume sale of undistributed lots after testing results confirm Accel-Ondansetron ODT is safe and effective to use
After reviewing the bioequivalence test data provided by Accel Pharma Inc., Health Canada has confirmed that Accel-Ondansetron ODT (4 mg and 8 mg tablets) are equivalent to their brand name counterparts and are safe and effective to use. As a result, the company has resumed the sale of undistributed units from lots CDX00123 and CEA00123 (listed above).
Original Advisory: June 7, 2024
Three companies (Accel Pharma Inc., Mint Pharmaceuticals Inc., and Pharmascience Inc.) are recalling all lots listed in the Affected Products table (above) due to concerns about the integrity of tests that are used to show that their generic prescription drugs work the same as brand-name versions.
Health Canada's authorization of the affected products relied on the bioequivalence test data. Bioequivalence data is used to demonstrate that generic drugs are equivalent to their brand-name counterparts.
The bioequivalence tests were conducted by Synapse Labs Pvt. Ltd., a contract research organization in Pune, Maharashtra, India. An inspection by a member of the European Medicines Agency, a trusted regulatory partner, found that data produced by Synapse Labs can no longer be relied upon to show this bioequivalence. As a result, the affected products can no longer be considered safe and effective. At Health Canada's request, the companies have stopped sale and have recalled all lots of the affected products until they can provide additional information to demonstrate that the products are safe and effective.
Health Canada is monitoring the effectiveness of the recalls and will take appropriate and timely action if any new health risks are identified.
What you should do
-- Return the affected products to your local pharmacy for a replacement,
and for proper disposal. If you are unsure whether your product is
affected, check with your pharmacy.
-- Consult a health care professional if you have used the affected product
and you have health concerns.
-- Report any health product-related side effects or complaints to Health
Canada.
-- Contact the companies if you have questions about their recall:
-- Accel Pharma Inc., by contacting Betty Cory at Accel Quality
Assurance by calling (416) 271-4775, or by email at bcory@regxia.com
-- Mint Pharmaceuticals Inc., by contacting Olenka Crewe at Mint
Pharmaceuticals Inc. Scientific Affairs by calling (416)-803-9151,
or by email at olenkac@mintpharmaceuticals.com
-- Pharmascience Inc. by calling, toll-free, at 1-800-340-9735, or by
email at customercarePms@pharmascience.com
Background
Accel-Ondansetron ODT is used to prevent nausea and vomiting related to chemotherapy in patients 4 years of age and older, radiotherapy in adults 18 years of age and older, and after surgery in adults 18 to 64 years of age. Receiving too little ondansetron could lead to reduced efficacy (i.e., increased risk of nausea and vomiting). Severe cases can lead to dehydration, loss of appetite, malnutrition, electrolyte imbalances, weight loss and fatigue. If used after surgery, severe nausea and vomiting might lead to complications such as wound opening and infection. Receiving too much ondansetron could lead to serotonin syndrome, a serious drug reaction caused by medications that build up high levels of serotonin in the body. Symptoms of serotonin syndrome can be mild, such as shivering and diarrhea, or severe, such as seizures, muscle rigidity and fever, and changes in heart rate and blood pressure. Too much ondansetron can affect heart rhythm and lead to sudden cardiac arrest. The heart-related effects and serotonin syndrome can both be fatal if untreated.
Mint-Betahistine is used for reducing the episodes of recurrent vertigo (dizziness) associated with Ménière's disease in adults 18 years of age and older. Receiving too little betahistine could lead to reduced efficacy and inadequate disease treatment. Unexpected vertigo episodes can lead to accidents and injuries, which can have serious consequences. Receiving too much betahistine could lead to headaches, nausea, and upset stomach.
PMS-Pirfenidone is used to treat a serious, long-term lung disease known as idiopathic pulmonary fibrosis (IPF) in adults 18 years of age and older. Receiving too little pirfenidone could lead to reduced efficacy and inadequate disease treatment, resulting in worsening symptoms and disease progression. Receiving too much pirfenidone can lead to nausea, diarrhea, upset stomach, abdominal pain, decreased appetite, dizziness, headache, photosensitivity (sun) reaction and rash. It can also lead to drug-induced liver injury. Signs of liver injury include yellow skin or eyes (jaundice).
Change Log: 2025-06-17: Added update on the resumption of sale of Accel Pharma Inc. products.
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SOURCE Health Canada (HC)
