Extraneal (2019-03-22)
- Starting date:
- March 22, 2019
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69416
Recalled Products
Extraneal solution
Reason
Active pharmaceutical ingredient (Icodextrin) used in affected lots contains elevated levels of sodium hydroxide.
Depth of distribution
Healtcare Establishments, End users
Affected products
Extraneal solution
DIN, NPN, DIN-HIM
DIN 02240806
Dosage form
Solution
Strength
Calcium chloride 257 mg/L
Icodextrin 75 g/L
Magnesium chloride 51 mg/L
Sodium chloride 5.35 g/L
Sodium lactate 4.48 g/L
Lot or serial number
W9B28T0, W9C05T1
Companies
- Recalling Firm
-
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA
- Marketing Authorization Holder
-
Baxter Corporation
7125 Mississauga Road
Mississauga
L5N 0C2
Ontario
CANADA