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Perfusion NewswireWarnings and RecallsProtamine Sulfate Shortage

Protamine Sulfate Shortage

Products Affected – Description


Protamine Sulfate 10 mg/mL, American Pharmaceutical Partners (APP)
5 mL vials (NDC 63323-0229-05)
5 mL Novaplus vials (NDC 63323-0229-15)
25 mL vials (NDC 63323-0229-30)
25 mLNovaplus vials (NDC 63323-0229-35)


Reason for the Shortage




  • APP has protamine on shortage due to increased demand.
  • There are no other manufacturers of protamine sulfate.


Estimated Resupply Dates




  • APP has protamine sulfate 10 mg/mL 5 mL and 25 mL vials on allocation.
  • APP has 5 mL Novaplus vials available for direct order only because they have an expiration date of July, 2011. The 25 mL Novaplus vials are on back order and the company cannot estimate a release date.


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