Mint-Betahistine 8, 16 & 24mg: Data integrity concerns with product's bioequivalence data that could lead to incorrect dosing.
Brand(s)
Last updated
Summary
Product
Mint-Betahistine 8, 16 & 24mg
Issue
Health products - Product quality
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.
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; 2430152 |
| Mint-Betahistine 16mg | Mint-Betahistine 16mg | DIN 02538148 | Tablet | Betahistine Hydrochloride 16 mg | 2330705, 2330945, 2330946, 2330947, 2430153 |
| Mint-Betahistine 24 mg | Mint-Betahistine 24 mg | DIN 02538156 | Tablet | Betahistine Hydrochloride 24 mg | 2330706A, 2430154 |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type I
Identification number
RA-75634
Get notified
Receive notifications for new and updated recalls and alerts by category.