Osmotic Laxative, Blood Coagulation Factor
Where is Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride and Dextro made?
4 companies sell it under their own name. Their labels name 4 factories in China, Singapore, Mexico and Ireland.
China 1Singapore 1Mexico 1Ireland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Vantive US Healthcare LLC5 ingredients · NDC 0941-0696, 0941-0698, 0941-0705 +5 | Baxter Healthcare (Guangzhou) Co., LtdMakes it, tests it, packages it, labels it and sterilizes it | Guangzhou, China | Problems found, fixed voluntarilyDec 2024 |
| Vantive Manufacturing Pte. Ltd.Makes it, tests it, packages it, labels it and sterilizes it | Singapore, Singapore | Serious problems, FDA actionDec 2024 | |
| Vantive US Healthcare LLC DIANEAL PD-2 with Dextrose, DIANEAL Low Calcium with Dextrose5 ingredients · NDC 0941-0733, 0941-0735, 0941-0727 +14 | Baxter, S.A. de C.V.Makes it, makes the active ingredient, tests it, packages it, labels it and sterilizes it | Jiutepec, Mexico | No problems foundDec 2018 |
| Vantive Manufacturing LimitedMakes it, tests it, packages it, labels it and sterilizes it | Castlebar, Ireland | Problems found, fixed voluntarilyDec 2022 | |
| Fresenius Medical Care Renal Therapies Group, LLC Delflex5 ingredients · NDC 49230-191, 49230-188, 49230-206 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Fresenius Medical Care de Mexico, S.A. de C.V. Delflex5 ingredients · NDC 46163-209, 46163-212, 46163-206 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Jun 18, 2024 · Class II · Fresenius Medical Care Holdings, Inc.
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect. - Jun 17, 2024 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component. - Dec 28, 2023 · Class II · Fresenius Medical Care Holdings, Inc.
Lack of Sterility Assurance - 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. - Apr 28, 2021 · Class III · Fresenius Medical Care Holdings, Inc. · 5 recall notices
Temperature Abuse: Product exposed to temperature outside specified limits. - Apr 14, 2021 · Class II · Fresenius Medical Care, North America
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box. - Jan 2, 2019 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. - Dec 20, 2017 · Class II · Fresenius Medical Care Renal Therapies Group, LLC
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag. - 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.