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1/22/2021

Amino Acid Products

Products Affected - Description

    • 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
    • Clinisol (sulfite-free) injection, Baxter, 15%, 2000 mL flexible container, 6 count, NDC 00338-0502-06
    • 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
    • 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
    • Prosol (sulfite-free) injection, Baxter, 20%, 2000 mL flexible container, 6 count, NDC 00338-0499-06
    • 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
    • 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 - discontinued

Reason for the Shortage

    • Baxter has amino acid presentations on shortage due to increased demand.
    • BBraun has Plenamine on shortage due to active ingredient shortage. BBraun has discontinued the production of ProcalAmine and the company estimates supplies will be depleted by May 2021. BBraun has discontinued the production of FreAmine III and the company estimates supplies will be depleted by February 2021.
    • ICU Medical has Aminosyn on shortage due to shortage of active ingredient.

Available Products

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

Estimated Resupply Dates

    • Baxter has Premasol 10% 500 mL, 1,000 mL, and 2,000 mL bottles on allocation. Prosol 20% 2,000 mL bottles are on allocation. Travasol 10% 500 mL, 1,000 mL, and 2,000 mL bottles are on back order and the company estimates release dates in late-March 2021. All Clinisol presentations are on allocation.
    • BBraun has Trophamine 10% 500 mL glass containers, Plenamine 15% 1,000 mL flexible containers, and FreAmine III 10% 1,000 mL glass containers on allocation.
    • ICU Medical has Aminosyn-PF 7% 500 mL containers on allocation. Aminosyn-PF 10% 1000 mL containers and both Aminosyn II presentations are available to contracted customers.

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: http://www.nutritioncare.org/News/General_News/Parenteral_Nutrition_Amino_Acids_Product_Shortage_Considerations/

Updated

Updated January 22, 2021 by Leslie Jensen, PharmD, Drug Information Specialist. Created May 21, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

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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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