Drug Shortage Report for DIANEAL PD4 CAPD SOLUTION WITH 1.5% DEXTROSE AND 2.5MEQ/L CALCIUM

Last updated on 2018-02-07
Report ID 37069
Drug Identification Number 00865095
Brand name DIANEAL PD4 CAPD SOLUTION WITH 1.5% DEXTROSE AND 2.5MEQ/L CALCIUM
Common or Proper name Dianeal PD4 w/ 1.5% Dextrose & 1.25 mmol/L Calcium
Company Name BAXTER CORPORATION
Active Ingredient(s) SODIUM LACTATE DEXTROSE MAGNESIUM CHLORIDE CALCIUM CHLORIDE SODIUM CHLORIDE
Strength(s) 448MG 1.5G 5.08MG 18.3MG 538MG
Dosage form(s) SOLUTION
Route of administration DIALYSIS
Packaging size 5L
ATC code B05ZA
ATC description HEMODIALYTICS AND HEMOFILTRATES
Reason for shortage Shortage of an inactive ingredient or component.
Anticipated start date 2018-01-24
Actual start date 2018-01-24
Estimated end date 2018-02-06
Actual end date 2018-02-06
Shortage status Resolved
Updated date 2018-02-06
Company comments As we work closely with our Supply Chain Operations to minimize the impact to both renal programs and patients, we are implementing a temporary allocation on the affected codes. Effective immediately, Baxter will be contacting all impacted patients and managing their inventory and shipments on a weekly basis or as required. In doing so, we will be releasing a reduced amount of product supply that is sufficient per patient therapy. Multiple shipments will take place to the patient’s home, and we will minimize substitutions unless clinically required. The manufacturing facility supplying the raw material component has advised that they have identified the root cause of the issue, corrective actions have been taken, and supply of new componentry will be shipped to our Alliston facility later this week. We thus expect to have replacement production occurring in coming days. More definitive timelines will be provided once replacement production occurs and finished goods testing is underway.
Health Canada comments
Contact Address 7125 MISSISSAUGA ROAD
MISSISSAUGA, ONTARIO
CANADA L5N 0C2
Company contact information