Drug Shortage Report for PROTAMINE SULFATE INJECTION, USP

Last updated on 2022-08-04 History
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
Shortage status Actual shortage
Updated date 2022-08-04
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

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