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2/21/2020

Amino Acid Products

Products Affected - Description

    • 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
    • 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
    • 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
    • ProcalAmine injection, BBraun, 1000 mL glass container, 6 count, NDC 00264-1915-07

Reason for the Shortage

    • Baxter has Premasol, Travasol, Prosol, and Clinisol available.
    • BBraun did not provide a reason for the shortage.
    • ICU Medical did not provide a reason for the shortage.

Available Products

    • Aminosyn II (sulfite-free) injection, ICU Medical, 10%, 2000 mL flexible container, 6 count, NDC 00409-7172-17
    • Aminosyn-PF (sulfite-free) injection, ICU Medical, 7%, 500 mL flexible container, 12 count, NDC 00409-4178-03
    • Clinisol (sulfite-free) injection, Baxter, 15%, 2000 mL flexible container, 6 count, NDC 00338-0502-06
    • Premasol (sulfite-free) injection, Baxter, 10%, 1000 mL flexible container, 12 count, NDC 00338-1130-04
    • 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%, 2000 mL flexible container, NDC 00338-0644-06
    • Travasol injection, Baxter, 10%, 500 mL flexible container, 6 count, NDC 00338-0644-03

Estimated Resupply Dates

    • BBraun has Trophamine, Plenamine, FreAmine III, and HepatAmine on allocation to contracted customers. Product will be allocated as it becomes available. ProcalAmine is on intermittent back order and the company is releasing product as it becomes available.
    • ICU Medical has 15% Aminosyn II 2,000 mL bags available to contracted customers only. The 10% Aminosyn-PF 1,000 mL bags are on back order and the company estimates a release date of late-February 2020.

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 February 21, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 21, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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