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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

  1. 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 02397838
Dosage 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