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Apo-Topiramate (2013-09-10)

Report a Concern
Starting date:
September 10, 2013
Posting date:
September 23, 2013
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-35859

Recalled Products

A. Apo-Topiramate, 25 mg

B. Apo-Topiramate, 100 mg

C. Apo-Topiramate, 200 mg

Reason

Lots may not meet the registered limit for sulfate during the shelf life of the product.

Depth of distribution

Wholesalers/Distributors - Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland, Nova Scotia, Ontario, Quebec, Saskatchewan.

Affected products

A. Apo-Topiramate, 25 mg

DIN, NPN, DIN-HIM
DIN 02279614
Dosage form

Tablets

Strength
  • Topiramate, 25 mg
Lot or serial number
  • KE4670
  • KK3664
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-Topiramate, 100 mg

DIN, NPN, DIN-HIM
DIN 02279630
Dosage form

Tablets

Strength
  • Topiramate, 100 mg
Lot or serial number
  • JY2391
  • KF1425
  • KL5757
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-Topiramate, 200 mg

DIN, NPN, DIN-HIM
DIN 02279649
Dosage form

Tablets

Strength
  • Topiramate, 200 mg
Lot or serial number
  • KF1436
  • KK7540
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