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11/14/2018

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%, 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

Estimated Resupply Dates

    • All marketed presentations are available.

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 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.

Updated

Updated November 14, 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.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Vizient, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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