One lot of Aminosyn® II, 15%, an amino acid injection, sulfite free intravenous (IV) solution is being recalled due to the presence of visible particulate matter.
Aminosyn II infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. It can also be administered peripherally with dilute dextrose solution and IV fat emulsion as a source of nutritional support.
Through central vein infusion, Aminosyn II can be used to prevent or reverse negative nitrogen balance in patients where the alimentary tract, by the oral, gastrostomy, or jejunostomy route cannot or should not be used and gastrointestinal absorption of protein is impaired.
Though acquired by ICU Medical, the affected product contains a Hospira NDC number and label. According to ICU Medical, 2112 units are affected by this recall and include the following information for identification:
- NDC: 0409-7171-17
- Product description: Aminosyn® II 15% An Amino Acid Injection, Sulfite-Free
- Lot number: 4989094
- Expiration date: April 1, 2022
- Configuration: Pharmacy bulk package 2-liter flexible container
- Manufacture date: November 2020
- Distribution dates: January 2021-March 2021
The particulates identified during a routine inspection included fibers, hair and proteinaceous material. Administration of a product containing particulate matter can result in inflammation at the injection site or possible thrombosis. At this time, there have been no reports of adverse events related to this recall.
Individuals with questions should contact ICU Medical at (844) 654-7780; the Company is notifying distributors and customers about the recalled products with a letter.
Quality problems and adverse events should also be reported to the FDA’s MedWatch program.
ICU Medical issues a voluntary nationwide recall of Aminosyn II 15%, an amino acid injection, sulfite free IV solution due to the presence of particulate matter. News release. September 3, 2021. https://www.prnewswire.com/news-releases/icu-medical-issues-a-voluntary-nationwide-recall-of-aminosyn-ii-15-an-amino-acid-injection-sulfite-free-iv-solution-due-to-the-presence-of-particulate-matter-301369280.html.