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Flolan (2015-03-20)
- Starting date:
- March 20, 2015
- Posting date:
- March 24, 2015
- 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-52679
Recalled Products
Flolan
Reason
An out-of-specification result for known impurity during stability study.
Depth of distribution
Retail
Affected products
Flolan
DIN, NPN, DIN-HIM
DIN 02230848
Dosage form
Powder for solution
Strength
Epoprostenol (Epoprostenol Sodium) 1.5 mg/vial
Lot or serial number
N440
Companies
- Recalling Firm
-
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga
L5N 6L4
Ontario
CANADA
- Marketing Authorization Holder
-
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga
L5N 6L4
Ontario
CANADA