Baxter Addresses Temporary Importation of Intravenous Drug Products to Address Drug Shortages

PUBLISHED: Dec 1, 2017
Relevant to: Ambulatory Care, Critical Access Hospitals, Dialysis Facilities, Home Health, Hospice, Hospitals, Long Term Care, Medical Office/Clinic, Pharmacies

Baxter has issued a letter to healthcare professionals addressing their response and actions in response to shortages of critical drug products from the aftermath of Hurricane Maria. Baxter Healthcare Corporation (Baxter) is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of products from Baxter’s manufacturing facility in Italy.

In the letter Baxter states, it has initiated temporary importation of Primene 10% Solution for Infusion, 250 mL, in glass container, which contains amino acids and is indicated for use in children, infants, and neonates. This product is manufactured by Baxter’s manufacturing facility in Italy and marketed in Europe. At this time, no other entity except Baxter is authorized by the FDA to import or distribute these products in the United States. The FDA has not approved the product manufactured by Baxter’s manufacturing facility in Italy.

Effective immediately, and during this temporary period, Baxter will offer the following:

  • Primene 10% Solution for Infusion in glass container
  • 250 mL
  • Product code: FCA3CG133R79D
  • NDC Code: 0338-9577-10

The letter from Baxter includes several important notes that should be reviewed before using Primene 10% solution for infusion. A copy of the letter is provided below.

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