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8/19/2019

Amino Acid Products

Products Affected - Description

    • Clinisol (sulfite-free) injection, Baxter, 15%, 2000 mL flexible container, 6 count, NDC 00338-0502-06
    • Premasol (sulfite-free) injection, Baxter, 10%, 2000 mL flexible container, 6 count, NDC 00338-1130-06
    • Premasol (sulfite-free) injection, Baxter, 10%, 500 mL flexible container, 24 count, NDC 00338-1130-03
    • Travasol injection, Baxter, 10%, 1000 mL flexible container, 12 count, NDC 00338-0644-04
    • Travasol injection, Baxter, 10%, 500 mL flexible container, 6 count, NDC 00338-0644-03
    • TrophAmine injection, BBraun, 10%, 500 mL glass container, 6 count, NDC 00264-9341-55
    • HepatAmine, BBraun, 8%, 500 mL glass container, 6 count, NDC 00264-9371-55

Reason for the Shortage

    • Baxter did not provide a reason for the shortage. Baxter discontinued Premasol 6% in late-2018.
    • BBraun did not provide a reason for the shortage.
    • ICU Medical has Aminosyn presentations available. ICU Medical discontinued several Aminosyn products in September 2018.

Available Products

    • Aminosyn II (sulfite-free) injection, ICU Medical, 10%, 2000 mL flexible container, 6 count, NDC 00409-7172-17
    • Aminosyn II (sulfite-free) injection, ICU Medical, 15%, 2000 mL flexible container, 6 count, NDC 00409-7171-17
    • Aminosyn-PF (sulfite-free) injection, ICU Medical, 10%, 1000 mL flexible container, 6 count, NDC 00409-4179-05
    • Aminosyn-PF (sulfite-free) injection, ICU Medical, 7%, 500 mL flexible container, 12 count, NDC 00409-4178-03
    • FreAmine III injection, BBraun, 10%, 1000 mL glass container, 6 count, NDC 00264-9010-55
    • Plenamine injection, BBraun, 15%, 1000 mL flexible container, 8 count, NDC 00264-4500-00
    • ProcalAmine injection, BBraun, 1000 mL glass container, 6 count, NDC 00264-1915-07

Estimated Resupply Dates

    • BBraun has Trophamine 10% 500 mL and HepatAmine 8% 500 mL in glass containers on intermittent back order and the company is releasing supplies as they become available.
    • Baxter has all Premasol, Travasol, Prosol, and Clinisol solutions on allocation.

Implications for Patient Care

    • Travasol product information now includes dosage information for pediatric patients. Travasol product information can be found at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8543b5be-0f43-4891-9e56-d7c39fe839b5. A comparison chart of Premasol and Travasol is available at https://www.nutritioncare.org/uploadedFiles/Documents/Guidelines_and_Clinical_Resources/Comparison%20Chart%20of%20Premasol%20and%20Travasol.pdf.

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/).

Updated

Updated August 19, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. Created May 21, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. © 2019, 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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