4/11/2019

Amino Acid Products

Products Affected - Description

- 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

Reason for the Shortage

- 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]

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
- 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.

Updated

Updated April 11, 2019 by Anthony Trovato, PharmD, BCPS. Created March 3, 2017 by Leslie Jensen, PharmD, Drug Information Specialist. © 2019, 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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