This page has been archived on the Web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This page has been archived on the Web.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

Apo-Diltiaz CD (2013-12-17)

Starting date:
December 17, 2013
Posting date:
January 16, 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-37405

Recalled products

  1. Apo-Diltiaz CD 180 mg
  2. Apo-Diltiaz CD 240 mg
  3. Apo-Diltiaz CD 120 mg

Reason

Dissolution may not meet specification for 30 hours timepoint over shelf-life.

Depth of distribution

Wholesalers/distributors and retailers in Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Nova Scotia, Northwest Territories, Ontario, Prince Edward Island, Quebec, Saskatchewan.

Affected products

A. Apo-Diltiaz CD 180 mg

DIN, NPN, DIN-HIM

DIN 02230998

Dosage form

Controlled Delivery Capsules

Strength
  • 180 mg
Lot or serial number
  • KH1024
Companies
Recalling Firm

Apotex Inc.

150 Signet Drive

Toronto

M9L 1T9

Ontario

CANADA

Marketing Authorization Holder

Apotex Inc.

150 Signet Drive

Toronto

M9L 1T9

Ontario

CANADA



B. Apo-Diltiaz CD 240 mg

DIN, NPN, DIN-HIM

DIN 02230999

Dosage form

Controlled Delivery Capsules

Strength
  • 240 mg
Lot or serial number
  • KK3943
Companies
Recalling Firm

Apotex Inc.

150 Signet Drive

Toronto

M9L 1T9

Ontario

CANADA

Marketing Authorization Holder

Apotex Inc.

150 Signet Drive

Toronto

M9L 1T9

Ontario

CANADA



C. Apo-Diltiaz CD 120 mg

DIN, NPN, DIN-HIM

DIN 02230997

Dosage form

Controlled Delivery Capsules

Strength
  • 120 mg
Lot or serial number
  • KK3945
Companies
Recalling Firm

Apotex Inc.

150 Signet Drive

Toronto

M9L 1T9

Ontario

CANADA

Marketing Authorization Holder

Apotex Inc.

150 Signet Drive

Toronto

M9L 1T9

Ontario

CANADA


Date modified: