Osmotic Laxative, Amino Acid
Where is Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threo made?
1 company sell it under their own name. Their labels name 3 factories in the United States and Belgium.
United States 2Belgium 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation Clinimix E21 ingredients · NDC 0338-1142, 0338-1144, 0338-1113 +15 | 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 | |
| Baxter SAMakes it, tests it, packages it, labels it and sterilizes it | Lessines, Belgium | Problems found, fixed voluntarilyNov 2023 |
Recalls
- Jan 21, 2016 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: identified as dried skin. - Mar 23, 2015 · Class II · Baxter Healthcare Corp
Lack of Assurance of Sterility; increased complaints received for leaks - Nov 25, 2014 · Class II · Baxter Healthcare Corp.
Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal - Nov 18, 2013 · Class I · Baxter Healthcare Corp. · 2 recall notices
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.