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Amino Acid Products With Electrolytes and Calcium

Last Updated: April 18, 2018
Status: Current

Amino Acid Products With Electrolytes and Calcium

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%, 1000 mL bag, 6 count, NDC 00338-1142-03
    • Clinimix E 2.75/5 (sulfite-free) injection, Baxter, 2.75%/5%, 2000 mL bag, 4 count, NDC 00338-1107-04
    • Clinimix E 4.25/10 (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 4.25/25 (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 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
    • 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
    • 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. https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM584414.pdf

Estimated Resupply Dates

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

Safety

    • 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/).

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 can be found at: https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM584414.pdf. Call Baxter to place an order at 888-229-0001.

Updated

Updated April 18, 2018 by Leslie Jensen, PharmD, Drug Information Specialist. Created October 16, 2017 by Elyse MacDonald, PharmD, MS, BCPS. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

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