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PMS-Rosuvastatin (2014-12-31)
- Starting date:
- December 31, 2014
- Posting date:
- January 8, 2015
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43243
Recalled Products
PMS-Rosuvastatin
Reason
Recall of the products due to out of specification results in the stability testing for impurity degradation.
Depth of distribution
Wholesalerts and Retailers
Affected products
PMS-Rosuvastatin
DIN, NPN, DIN-HIM
DIN 02378566
Dosage form
Tablet
Strength
Rosuvastatine (Rosuvastatin Calcium) 40 mg
Lot or serial number
(L) 482560 (Bottle of 100 Tabs)
(L) 481460 (Blister packaging)
Companies
- Recalling Firm
-
Pharmascience Inc.
6111 Royalmount Ave., Suite 100
Montreal
H4P 2T4
Quebec
CANADA
- Marketing Authorization Holder
-
Pharmascience Inc.
6111 Royalmount Ave., Suite 100
Montreal
H4P 2T4
Quebec
CANADA