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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

  1. 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 02365367
Dosage 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

Apotex Product Recall (2015-04-10)

2015-04-10 | Health products

Recall
Recall