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APO-Candesartan / HCTZ Product Recall (2015-05-19)

Starting date:
May 19, 2015
Posting date:
May 21, 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-53497

Recalled products

  1. APO-Candesartan / HCTZ 12.5 mg
  2. APO-Candesartan / HCTZ 25 mg

Reason

Product lots KN9456, KP0842, KV0887, KP0050 did not meet the shelf life specification for CAD II impurity.

Product lots KN9458, KN9461, KV7989, KV0896 obtained results that were close to the specification limit for CAD II impurity (out of trend).

Product lot KV0886 did not meet the shelf life specification for CAD II impurity (result: 0.6%, limit: NMT 0.5%) during stability testing at 9 month time point.

Depth of distribution

Wholesalers

Affected products

A. APO-Candesartan / HCTZ 12.5 mg

DIN, NPN, DIN-HIM
DIN 02395126
Dosage form

Tablet

Strength
  • Candesartan Cilexetil 32 mg
  • Hydrochlorothiazide 12.5 mg
Lot or serial number
  • KN9456
  • KN9458
  • KN9461
  • KP0842
  • KV0886
  • KV0887
  • KV7989
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-Candesartan / HCTZ 25 mg

DIN, NPN, DIN-HIM
DIN 02395134
Dosage form

Tablet

Strength
  • Candesartan Cilexetil 32 mg
  • Hydrochlorothiazide 25 mg
Lot or serial number
  • KP0050
  • KV0896
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

Apotex Product Recall (2015-04-10)

2015-04-10 | Health products

Recall

APO-Candesartan 16 mg (2015-05-01)

2015-05-01 | Health products

Recall