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.