Amino Acid
Where is Lysine Acetate, Leucine, Phenylalanine, Valine, Isoleucine, Methionine, Threonin made?
2 companies sell it under their own name. Their labels name 2 factories in the United States.
United States 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation ProSol17 ingredients · NDC 0338-0502, 0338-0499 | Baxter Healthcare CorporationMakes it, tests it, packages it, labels it and sterilizes it | Marion, NC, United States | Serious problems, FDA actionFeb 2024 |
| Baxter Healthcare CorporationMakes it, tests it, packages it, labels it and sterilizes it | Jayuya, PR, United States | Problems found, fixed voluntarilyJul 2024 | |
| B. Braun Medical Inc.17 ingredients · NDC 0264-4500 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Aug 4, 2014 · Class II · Baxter Healthcare Corp
Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.