Drug Shortage Report for PROTAMINE SULFATE INJECTION, USP
| Report ID | 200334 |
| Drug Identification Number | 02139537 |
| Brand name | PROTAMINE SULFATE INJECTION, USP |
| Common or Proper name | PROTAMINE SULFATE INJECTION, USP |
| Company Name | FRESENIUS KABI CANADA LTD |
| Market Status | MARKETED |
| Active Ingredient(s) | PROTAMINE SULFATE |
| Strength(s) | 10MG |
| Dosage form(s) | SOLUTION |
| Route of administration | INTRAVENOUS INTRAVENOUS |
| Packaging size | 5 mL |
| ATC code | V03AB |
| ATC description | ALL OTHER THERAPEUTIC PRODUCTS |
| Reason for shortage | Other (Please describe in comments) |
| Anticipated start date | 2023-08-01 |
| Actual start date | 2023-08-01 |
| Estimated end date | 2023-10-15 |
| Actual end date | 2023-08-15 |
| Shortage status | Resolved |
| Updated date | 2023-08-16 |
| Company comments | Fresenius Kabi Canada regrets to advise that due to unforeseen circumstances, we will be encountering a supply interruption on our Protamine Sulfate Injection, USP 10 mg/mL SD Vial 5 mL effective August 1, 2023, until October 15, 2023. Effective August 1, 2023, our Protamine Sulfate Injection, USP 10 mg/mL SD Vial 25 mL will be placed on allocation. Contract customers will be allocated 100% of historical 25 mL demand plus 100% of historical 5 mL demand at a 5:1 ratio (5 vials of 5 mL = 1 vial of 25 mL). |
| Health Canada comments | |
| Tier 3 Status | No |
| Contact Address | 165 GALAXY BLVD, SUITE 100 TORONTO, ONTARIO CANADA M9W 0C8 |
| Company contact information |
Version History
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| Version Number | Date Updated | Language | |
|---|---|---|---|
| v6 | 2023-08-16 | English | Compare |
| v5 | 2023-08-15 | French | Compare |
| v4 | 2023-08-15 | English | Compare |
| v3 | 2023-08-02 | English | Compare |
| v2 | 2023-07-27 | French | Compare |
| v1 | 2023-07-27 | English | Compare |
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