Teva 5-ASA tablet (aka MESALAMINE): Out of Specification (Stability - Dissolution)
Brand(s)
Last updated
Summary
Product
Teva 5-ASA tablet (aka MESALAMINE)
Issue
Health products - Product quality
What to do
Consult your health care professional if you have any health concerns.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot numbers |
|---|---|---|---|---|---|
| Teva Canada | Teva 5-ASA tablet (aka MESALAMINE) | DIN 02171929 | Tablet (Enteric-Coated) | Mesalazine 400 mg | 100048018, 100037651, 100037650, 100053047 |
Issue
The Dissolution stability test is out of specification in the affected lots.
What you should do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Additional information
Background
Depth of recall: Retailers
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Teva Canada Limited
30 Novopharm Court,
Toronto ON M1B 2K9 Canada
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-77242
Get notified
Receive notifications for new and updated recalls and alerts by category.