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Health product recall

Tecfidera (2015-11-20)

Starting date:
November 20, 2015
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-55916

Affected Products

Tecfidera

Reason

Lot number discrepancy: Products were identified as having the lot number CANEDSLI00 instead of CANEDLSI00 (reversal of the letters “L” and “S”).

Depth of distribution

Wholesalers and provinces across Canada

Affected products

Tecfidera

DIN, NPN, DIN-HIM
DIN 02420201
Dosage form

Capsule

Strength

Dimethyl Fumarate 240 mg

Lot or serial number

(L) CANEDLS100

Companies
Recalling Firm
Biogen Canada Inc.
90 Burnhamthorpe Road West, Suite 1100
Mississauga
L5B 3C3
Ontario
CANADA
Marketing Authorization Holder
Biogen Canada Inc.
90 Burnhamthorpe Road West, Suite 1100
Mississauga
L5B 3C3
Ontario
CANADA

Date modified: