Osmotic Laxative, Blood Coagulation Factor
Where is Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride and Dextro made?
1 company sell it under their own name. Their labels name 3 factories in Mexico, Italy and Ireland.
Mexico 1Italy 1Ireland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Vantive US Healthcare LLC DIANEAL Low Calcium with Dextrose, Prismasolbgk0/2.55 ingredients, 6 ingredients · NDC 0941-0484, 0941-0487, 0941-0490 +1 | Baxter, S.A. de C.V.Makes it, tests it, packages it, labels it and sterilizes it | Jiutepec, Mexico | No problems foundDec 2018 |
| Bieffe Medital S.p.A.Makes it, tests it, packages it, labels it and sterilizes it | Sondalo, Italy | Problems found, fixed voluntarilyNov 2023 | |
| Vantive Manufacturing LimitedMakes it, tests it, packages it, labels it and sterilizes it | Castlebar, Ireland | Problems found, fixed voluntarilyDec 2022 |
Recalls
- Jun 17, 2024 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component. - Aug 11, 2023 · Class II · Baxter Healthcare Corporation · 2 recall notices
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. - Mar 15, 2023 · Class II · Baxter Healthcare Corporation · 2 recall notices
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. - Jan 2, 2019 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. - Aug 7, 2014 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: particulate matter was found during the manufacturing process. - Feb 11, 2014 · Class I · Baxter Healthcare Corp.
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch. - Jul 24, 2013 · Class II · Baxter Healthcare Corp.
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.