This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Archived

This page has been archived on the Web.

Health product recall

Atorvastatin Recall (2014-07-08)

Starting date:
July 8, 2014
Posting date:
August 12, 2014
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-40715

Recalled Products

  1. Atorvastatin, 10 mg
  2. Atorvastatin, 80 mg

Reason

The product content for related substances (Impurity B-Diepoxide Atorvastatin) will not meet specifications at the end of shelf life.

Depth of distribution

Wholesalers and pharmacies in Quebec

Affected products

A. Atorvastatin, 10 mg

DIN, NPN, DIN-HIM
DIN 02387891
Dosage form

Tablet

Strength

10 mg

Lot or serial number

35331998B

Companies
Recalling Firm
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA
Marketing Authorization Holder
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA

B. Atorvastatin, 80 mg

DIN, NPN, DIN-HIM
DIN 02387921
Dosage form

Tablet

Strength

80 mg

Lot or serial number

35206406A

Companies
Recalling Firm
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA
Marketing Authorization Holder
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA

Date modified: