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FDA notification regarding potassium phosphates injection

Stop Distributing Unapproved Potassium Phosphates Injection

FDA requested a company stop distributing unapproved versions of potassium phosphates injection on August 1, 2024.

The agency approved:

  • Fresenius Kabi’s potassium phosphates injection (NDCs 65219-052, 65219-054 and 65219-056) on November 26, 2019
  • American Regent’s potassium phosphates injection (NDCs 0517-2051, 0517-2102 and 20517-2505) on October 2, 2023
  • Amneal Pharmaceuticals’ potassium phosphates injection (NDCs 80830-1691, 80830-1692 and 80830-1693) on October 10, 2023
  • Somerset Therapeutics’ potassium phosphates injection (NDCs 70069-746 and 70069-747) on July 11, 2024

Unapproved Potassium Phosphates Injection that should not be Distributed in Interstate Commerce

All other potassium phosphates injection products are unapproved new drugs that should not be distributed in interstate commerce without a new drug application approved by FDA, including:

Drug NDC Drug name
0409-7295-11 Potassium phosphates injection, USP 15 mL in 1 vial
0409-7295-01 Potassium phosphates injection, USP 15 mL in 1 vial, 25 vials in 1 carton

FDA encourages all drug companies of unapproved drugs to seek FDA approval. The NDC Directory identifies FDA approval status of all prescription drug marketed in the United States.

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