Products Affected - Description

• • Clinimix E 2.75/10 (sulfite-free) injection, Baxter, 2.75%/10%, 1000 mL bag, 6 count, NDC 00338-1143-03
  • Clinimix E 2.75/10 (sulfite-free) injection, Baxter, 2.75%/10%, 2000 mL bag, 4 count, NDC 00338-1109-04
  • Clinimix E 2.75/5 (sulfite-free) injection, Baxter, 2.75%/5%, 2000 mL bag, 4 count, NDC 00338-1107-04
  • Clinimix E 4.25/25 (sulfite-free) injection, Baxter, 4.25%/25%, 1000 mL bag, 6 count, NDC 00338-1146-03
  • Clinimix E 4.25/25 (sulfite-free) injection, Baxter, 4.25%/25%, 2000 mL bag, 4 count, NDC 00338-1119-04
  • Clinimix E 5/25 (sulfite-free) injection, Baxter, 5%/25%, 1000 mL bag, 6 count, NDC 00338-1149-03
  • Clinimix E 5/25 (sulfite-free) injection, Baxter, 5%/25%, 2000 mL bag, 4 count, NDC 00338-1127-04

Reason for the Shortage

• • Baxter had Clinimix E with electrolytes plus calcium presentations on allocation due to delays because of the hurricane in Puerto Rico.
  • To help alleviate the critical drug shortages resulting from the aftermath of Hurricane Maria, FDA had allowed Baxter to temporarily import the following amino acid products: Clinimix N9G15E, Clinimix N9G20E, and Clinimix N14G30E solutions for infusion. Additional information can be found in the Dear Healthcare Professional Letter. https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM584414.pdf

Available Products

• • Clinimix E 2.75/5 (sulfite-free) injection, Baxter, 2.75%/5%, 1000 mL bag, 6 count, NDC 00338-1142-03
  • Clinimix E 4.25/10 (sulfite-free) injection, Baxter, 4.25%/10%, 1000 mL bag, 6 count, NDC 00338-1145-03
  • Clinimix E 4.25/10 (sulfite-free) injection, Baxter, 4.25%/10%, 2000 mL bag, 4 count, NDC 00338-1115-04
  • Clinimix E 4.25/5 (sulfite-free) injection, Baxter, 4.25%/5%, 1000 mL bag, 6 count, NDC 00338-1144-03
  • Clinimix E 4.25/5 (sulfite-free) injection, Baxter, 4.25%/5%, 2000 mL bag, 4 count, NDC 00338-1113-04
  • Clinimix E 5/15 (sulfite-free) injection, Baxter, 5%/15%, 1000 mL bag, 6 count, NDC 00338-1147-03
  • Clinimix E 5/15 (sulfite-free) injection, Baxter, 5%/15%, 2000 mL bag, 4 count, NDC 00338-1123-04
  • Clinimix E 5/20 (sulfite-free) injection, Baxter, 5%/20%, 1000 mL bag, 6 count, NDC 00338-1148-03
  • Clinimix E 5/20 (sulfite-free) injection, Baxter, 5%/20%, 2000 mL bag, 4 count, NDC 00338-1125-04

• • All marketed presentations are available.

• • ASPEN provides recommendations for managing shortages of parenteral nutrition products. See their website for more details (https://www.nutritioncare.org/Guidelines_and_Clinical_Resources/Product_Shortages/Product_Shortage_Management/).

• • FDA in conjunction with Baxter was allowing temporary importation of amino acid solutions with electrolytes and calcium from the United Kingdom. There were 3 different solutions being imported:
  • 1. CLINIMIX N9G15E-Solution for Infusion 1,000 mL (NDC 00338-9570-08) - 5.5% Amino Acids with Electrolytes (500 mL) and Glucose 15% with Calcium (500 mL) for a final mixture 2.75% Amino Acid in 7.5% Glucose with Electrolytes
  • 2. CLINIMIX N9G20E-Solution for Infusion 1,000 mL (NDC 00338-9566-08) - 5.5% Amino Acids with Electrolytes (500 mL) and Glucose 20% with Calcium (500 mL) for a final mixture of 2.75% Amino Acid in 10% Glucose with Electrolytes
  • 3. CLINIMIX N14G30E-Solution for Infusion 2,000 mL (NDC 00338-9578-04) - 8.5% Amino Acids with Electrolytes (1,000 mL) and Glucose 30% with Calcium (1,000 mL) for a final mixture of 4.25% Amino Acid in 15% Glucose with Electrolytes
  • Detailed information on ordering and differences between the UK and US products can be found at: https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM584414.pdf. Call Baxter to place an order at 888-229-0001.