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Health product recall

PMS-Amlodipine-Atorvastatin (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-43239

Recalled Products

PMS-Amlodipine-Atorvastatin

Reason

This lot is not complaint to the specifications for a known degradation product (12 months stability testing)

Depth of distribution

Retailers

Affected products

PMS-Amlodipine-Atorvastatin

DIN, NPN, DIN-HIM
DIN 02404249
Dosage form

Tablets

Strength

Amlodipine (Amlodipine Besylate)  10 mg
Atorvastatin (Atorvastatin Calcium)  10 mg

Lot or serial number

473863

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: