Mint-Rosuvastatin Tablet products recall; Out of specification (Impurity)
Brand(s)
Last updated
Summary
Product
Mint-Rosuvastatin Tablet
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 |
|---|---|---|---|---|---|
| Mint Pharmaceuticals | Mint-Rosuvastatin 10 mg tablet | DIN 02397803 | Tablet | Rosuvastatin calcium 10 mg | 14240935B, 14240936B, 14240937A, 14240934A, 14240935A, 14240936A |
| Mint Pharmaceuticals | Mint-Rosuvastatin 20 mg tablet | DIN 02397811 | Tablet | Rosuvastatin calcium 20 mg | 14240938A, 14240939A, 14240940A, 14240938B, 14240939B, 14240940B |
| Mint Pharmaceuticals | Mint-Rosuvastatin 40 mg tablet | DIN 02397838 | Tablet | Rosuvastatin calcium 40 mg | 14240941A, 14240942A |
Issue
The Impurity 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: Wholesalers
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Mint Pharmaceuticals Inc
6575 Davand Drive,
Mississauga, ON L5T 2M3
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type III
Identification number
RA-77183
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