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 | |
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v1 | 2022-08-04 | English | Compare |
v2 | 2022-08-04 | French | Compare |
v3 | 2022-09-12 | English | Compare |
v4 | 2022-09-12 | French | Compare |
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