Mint-Betahistine 8, 16 & 24mg: Data integrity concerns with product's bioequivalence data that could lead to incorrect dosing.
Brand(s)
Summary
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.
Affected products
Brand |
`Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot |
|---|---|---|---|---|---|
Mint-Betahistine 8 mg |
Mint-Betahistine 8 mg |
DIN 02538121 |
Tablet |
Betahistine Hydrochloride 8 mg |
2330704; |
Mint-Betahistine 16mg |
Mint-Betahistine 16mg |
DIN 02538148 |
Tablet |
Betahistine Hydrochloride 16 mg |
2330705, |
Mint-Betahistine 24 mg |
Mint-Betahistine 24 mg |
DIN 02538156 |
Tablet |
Betahistine Hydrochloride 24 mg |
2330706A, |
Issue
Data integrity concerns with product's bioequivalence data that could lead to incorrect dosing.
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
Additional information
Previous recalls or alerts
Background
Depth of recall: Retailers
Details
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