PMS-PIRFENIDONE 267 & 801 mg: Data integrity concerns with products bioequivalence data that could lead to incorrect dosing.
Brand(s)
Last updated
Summary
Product
PMS-PIRFENIDONE 267 & 801 mg
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 |
|---|---|---|---|---|---|
PMS-PIRFENIDONE |
PMS-PIRFENIDONE 267mg |
DIN 02531526 |
Tablet |
PIRFENIDONE 267mg |
E0800A, |
PMS-PIRFENIDONE |
PMS-PIRFENIDONE 801mg |
DIN 02531534 |
Tablet |
PIRFENIDONE 801mg |
E0802A, E0802C |
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
|
Pharmascience Montréal, Québec H4P 2T4 |
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type I
Identification number
RA-75642
Get notified
Receive notifications for new and updated recalls and alerts by category.