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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

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