Health product recall

Dianeal PD4 CAPD (2019-11-13)

Starting date:
November 13, 2019
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-71654



Last updated: 2019-11-20

Summary

  • Product:
    Dianeal PD4 CAPD Solution with 1.5% Dextrose and 2.5 MEQ/L Calcium

Reason

Affected lot was released to market without adequate testing

Depth of distribution

End users

Affected products

Dianeal PD4 CAPD Solution with 1.5% Dextrose and 2.5 MEQ/L Calcium

DIN, NPN, DIN-HIM

DIN 00865095

Dosage form

Solution

Strength

Calcium chloride 18.3 mg/100 mL

Dextrose 1.5 g/100 mL

Magnesium chloride 5.08 mg/100 mL

Sodium chloride 538 mg/100 mL

Sodium lactate 448 mg/100 mL

Lot or serial number

W9G11T0

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