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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