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Topiramate (2013-09-13)

Report a Concern
Starting date:
September 13, 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-35861

Recalled Products

A. Topiramate, 25.0 mg

B. Topiramate, 100.0 mg

Reason

The indicated lots may not meet the registered limit for sulfate toward the end of shelf life.

Depth of distribution

Wholesalers in the province of Quebec.

Affected products

Topiramate, 25.0 mg

DIN, NPN, DIN-HIM
DIN 02389460
Dosage form

Tablet

Strength
  • Topiramate, 25.0 mg
Lot or serial number
  • KE4385
Companies
Recalling Firm
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Ville Saint-Laurent
H4R 2P7
Quebec
CANADA
Marketing Authorization Holder
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Ville Saint-Laurent
H4R 2P7
Quebec
CANADA

Topiramate, 100.0 mg

DIN, NPN, DIN-HIM
DIN 02389487
Dosage form

Tablet

Strength
  • Topiramate, 100.0 mg
Lot or serial number
  • KE4383
Companies
Recalling Firm
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Ville Saint-Laurent
H4R 2P7
Quebec
CANADA
Marketing Authorization Holder
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Ville Saint-Laurent
H4R 2P7
Quebec
CANADA