Drug Shortage Report for DIANEAL PD4 CAPD SOLUTION WITH 2.5% DEXTROSE AND 2.5MEQ/L CALCIUM
| Report ID | 37066 |
| Drug Identification Number | 00865109 |
| Brand name | DIANEAL PD4 CAPD SOLUTION WITH 2.5% DEXTROSE AND 2.5MEQ/L CALCIUM |
| Common or Proper name | Dianeal, PD4 w/ 2.5% Dextrose & 1.25 mmol/L Calcium |
| Company Name | VANTIVE ULC |
| Market Status | MARKETED |
| Active Ingredient(s) | SODIUM LACTATE DEXTROSE MAGNESIUM CHLORIDE CALCIUM CHLORIDE SODIUM CHLORIDE |
| Strength(s) | 448MG 2.5G 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 | 2018-02-08 |
| Actual end date | 2018-02-08 |
| Shortage status | Resolved |
| Updated date | 2018-02-09 |
| 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 | |
| Tier 3 Status | No |
| Contact Address | 6675 MILLCREEK DRIVE, UNIT 2 MISSISSAUGA, ONTARIO CANADA L5N 5M4 |
| Company contact information |
Version History
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| Version Number | Date Updated | Language | |
|---|---|---|---|
| v6 | 2018-02-09 | English | Compare |
| v5 | 2018-02-08 | French | Compare |
| v4 | 2018-02-08 | English | Compare |
| v3 | 2018-01-25 | English | Compare |
| v2 | 2018-01-24 | French | Compare |
| v1 | 2018-01-24 | English | Compare |
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