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Mint-Rosuvastatin (2014-08-27)
- Starting date:
- August 27, 2014
- Posting date:
- September 15, 2014
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41373
Recalled products
- Mint-Rosuvastatin
Reason
During a post-market stability testing, it was discovered that there was a failure at three month long-term stability station. The product was high out of specification for total impurities at the 15-month time point.
Depth of distribution
Wholesalers and Retailers in Ontario, Quebec, British Columbia, Alberta, Newfoundland and Labrador and Manitoba
Affected products
A. Mint-Rosuvastatin
DIN, NPN, DIN-HIM
DIN 02397838Dosage form
- Tablet
Strength
- 40 mg
Lot or serial number
- 140001A
Companies
- Recalling Firm
-
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit #1
Mississauga
L5T 1J6
Ontario
CANADA
- Marketing Authorization Holder
-
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit #1
Mississauga
L5T 1J6
Ontario
CANADA