Amino Acid Products Shortage

• • Premasol (sulfite-free) injection, Baxter, 6%, 500 mL flexible container, 24 count, NDC 00338-1131-03 - discontinued
  • TrophAmine injection, BBraun, 6%, 500 mL glass container, 12 count, NDC 00264-9361-55 - discontinued
  • FreAmine HBC injection, BBraun, 6.9%, 750 mL glass container, 6 count, NDC 00264-9350-55 - discontinued
  • NephrAmine injection, BBraun, 5.4%, 250 mL glass container, 6 count, NDC 00264-1909-55 - discontinued

• • Baxter discontinued Premasol in late-2018. The remaining amino acid products are available.[1]
  • BBraun discontinued FreAmine HBC, Nephramine, and Trophamine 6% in mid-2018. The remaining amino acid presentations are available.[2]
  • ICU Medical discontinued several Aminosyn products in September 2018. The remaining amino acid presentations are available.[3]

• • 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
  • Clinisol (sulfite-free) injection, Baxter, 15%, 500 mL flexible container, 24 count, NDC 00338-0502-03
  • FreAmine III injection, BBraun, 10%, 1000 mL glass container, 6 count, NDC 00264-9010-55
  • Plenamine injection, BBraun, 15%, 1000 mL glass container, 6 count, NDC 00264-3200-55
  • 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
  • ProcalAmine injection, BBraun, 1000 mL glass container, 6 count, NDC 00264-1915-07

Estimated Resupply Dates

• • All marketed presentations are available.

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/).

References

• 1. Baxter. Customer Service (personal communications). September 6, 2017, January 3, February 28, June 8, July 9, November 15, December 3, 2018; February 11 and April 8, 2019.
  2. BBraun. Customer Service (personal communications). June 12 and December 6, 2017; July 10 and November 26, 2018.
  3. ICU Medical. Customer Service (personal communications or website). September 6 and December 6, 2017, February 28, April 2 and 9, May 1, July 10, August 15, October 6, November 15, 2018; February 6 and March 25, 2019.
  4. Baxter. Dear Healthcare Professional Letter. https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM587200.pdf November 30, 2017. Accessed December 6, 2017.
  5. Baxter. Dear Healthcare Professional Letter. https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM584416.pdf Accessed December 15, 2017.