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Soliris (2014-06-06)
- Starting date:
- June 6, 2014
- Posting date:
- July 11, 2014
- 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-40375
Recalled Products
Soliris
Reason
Due to the presence of visible particles in a limited number of vials from a lot of Soliris which was distributed in another market. Lots which were manufactured using the same process are being recalled.
Depth of distribution
Hospitals/Pharmacies across Canada
Affected products
Soliris
DIN, NPN, DIN-HIM
DIN 02322285Dosage form
Solution
Strength
Eculizumab - 10 mg/ml
Lot or serial number
- 00015A
- 00017E
- 00020C
Companies
- Recalling Firm
-
Alexion Pharma Canada Corp
400 Applewood Crescent, Suite 120
Vaughan
Ontario
CANADA
- Marketing Authorization Holder
-
Alexion Pharma International, SARL
34 Avenue du Tribunal Federal Switzerland
Lausanne
1005
SWITZERLAND