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Amino Acid Products with Electrolytes in Dextrose with Calcium (Clinimix E)

Last Updated: February 28, 2018
Status: Resolved

Amino Acid Products with Electrolytes in Dextrose with Calcium (Clinimix E)

Products Affected - Description
  • Clinimix E 2.75/10 (sulfite-free) injection, Baxter
    2.75%/10%, 1000 mL bag, 6 count (NDC 00338-1143-03)
    2.75%/10%, 2000 mL bag, 4 count (NDC 00338-1109-04)

    Clinimix E 2.75/5 (sulfite-free) injection, Baxter
    2.75%/5%, 1000 mL bag, 6 count (NDC 00338-1142-03)
    2.75%/5%, 2000 mL bag, 4 count (NDC 00338-1107-04)

    Clinimix E 4.25/10 (sulfite-free) injection, Baxter
    4.25%/10%, 1000 mL bag, 6 count (NDC 00338-1145-03)
    4.25%/10%, 2000 mL bag, 4 count (NDC 00338-1115-04)

    Clinimix E 4.25/25 (sulfite-free) injection, Baxter
    4.25%/25%, 1000 mL bag, 6 count (NDC 00338-1146-03)
    4.25%/25%, 2000 mL bag, 4 count (NDC 00338-1119-04)

    Clinimix E 4.25/5 (sulfite-free) injection, Baxter
    4.25%/5%, 1000 mL bag, 6 count (NDC 00338-1144-03)
    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)
    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)
    5%/20%, 2000 mL bag, 4 count (NDC 00338-1125-04)

    Clinimix E 5/25 (sulfite-free) injection, Baxter
    5%/25%, 1000 mL bag, 6 count (NDC 00338-1149-03)
    5%/25%, 2000 mL bag, 4 count (NDC 00338-1127-04)

 
Imported Products
Clinimix N14G30E (sulfite-free) injection, Baxter
4.25%/15%, 2000 mL bag, 4 count (NDC 00338-9587-04)

Clinimix N9G15E (sulfite-free) injection, Baxter
2.75%/7.5%, 1000 mL bag, 8 count (NDC 00338-9570-08)

Clinimix N9G20E (sulfite-free) injection, Baxter
2.75%/10%, 1000 mL bag, 8 count (NDC 00338-9566-08)
Reason for the Shortage
    • Baxter has all 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 has 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
Available Products
  • There is insufficient supply for usual ordering.

Estimated Resupply Dates

  • Baxter has all amino acid products with electrolytes plus calcium on allocation.

Safety

Alternative Agents & Management

    • FDA in conjunction with Baxter is allowing temporary importation of amino acid solutions with electrolytes and calcium from the United Kingdom. There are 3 different solutions being imported at this time:
    • 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. Call Baxter to place an order at 888-229-0001

Updated

February 28, January 3, 2018; December 20, November 10, October 16, 2017, University of Utah, Drug Information Service. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

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