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Health product recall

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

Date modified: