Reason for the Shortage

• • American Regent has not had potassium phosphate injection available since 2012. It is unclear if and when product will return to market.
  • Fresenius Kabi had potassium phosphate injection on shortage due to increased demand.
  • Pfizer had potassium phosphate injection on shortage due to manufacturing delays.

Available Products

• • Potassium Phosphate injection, Fresenius Kabi, 3 mmol/mL, 15 mL vial, 25 count, NDC 63323-0086-15
  • Potassium Phosphate injection, Fresenius Kabi, 3 mmol/mL, 5 mL vial, 25 count, NDC 63323-0086-05
  • Potassium Phosphate injection, Fresenius Kabi, 3 mmol/mL, 50 mL vial, 25 count, NDC 63323-0086-50
  • Potassium Phosphate injection, Pfizer, 3 mmol/mL, 15 mL vial, 25 count, NDC 00409-7295-01
  • Glycophos injection, Fresenius Kabi, 1 mmol/mL, 20 mL vial, 10 count, NDC 63323-0241-20

• • All marketed presentations are available.

• • Pfizer has issued a recall on 7 lots of potassium phosphate 3 mmol/mL 15 mL vials due to sterility concerns. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563382.htm

• • In cooperation with FDA, Fresenius Kabi USA is providing Glycophos (sodium glycerophosphate) injection to the US market to help alleviate the shortage of phosphate injections. Glycophos is manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG. Details can be found on https://www.fda.gov/downloads/drugs/drugsafety/drugshortages/ucm591758.pdf