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APO-Candesartan 16 mg (2015-05-01)
- Starting date:
- May 1, 2015
- Posting date:
- May 4, 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-53251
Recalled products
- APO-Candesartan 16 mg
Reason
Apotex initiated recall of one additional lot of APO-Candesartan due to out of specification results during stability testing for CAD-II impurity.
Depth of distribution
Wholesalers
Affected products
A. APO-Candesartan 16 mg
DIN, NPN, DIN-HIM
DIN 02365367Dosage form
Tablet
Strength
- Candesartan cilexetil 16 mg
Lot or serial number
- KW0445
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