Drug Shortage Report for PROTAMINE SULFATE INJECTION, USP
| Report ID | 166155 |
| 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 | 25 mL |
| ATC code | V03AB |
| ATC description | ALL OTHER THERAPEUTIC PRODUCTS |
| Reason for shortage | Disruption of the manufacture of the drug. |
| Anticipated start date | |
| Actual start date | 2022-08-01 |
| Estimated end date | 2022-09-12 |
| Actual end date | 2022-09-07 |
| Shortage status | Resolved |
| Updated date | 2022-09-12 |
| Company comments | Fresenius Kabi Canada regrets to advise that due to a production delay, we will be encountering a supply interruption on our Protamine Sulfate Injection, USP 10 mg/mL SD Vial 25 mL effective August 1, 2022 until September 12, 2022. Effective August 1, 2022 until August 31, 2022, allocations for our Protamine Sulfate Injection, USP 10 mg/mL SD Vial 5 mL will be increased. Contract customers will be allocated 100% of historical monthly demand of 5 mL plus 40% of historical monthly demand of 25 mL. No coverage of the 25mL will be available in September. |
| 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 | |
|---|---|---|---|
| v4 | 2022-09-12 | French | Compare |
| v3 | 2022-09-12 | English | Compare |
| v2 | 2022-08-04 | French | Compare |
| v1 | 2022-08-04 | English | Compare |
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