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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
- APO-Candesartan / HCTZ 12.5 mg
- 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
Related AWRs