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