NDC 0941-0409
DIANEAL Low Calcium with Dextrose 5 ingredients injection, solution
On the label: Vantive US Healthcare LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter, S.A. de C.V. | Jiutepec, Mexico | Makes it, makes the active ingredient, tests it, packages it, labels it and sterilizes it | No problems foundDec 14, 2018 · 2 inspections |
Recalls
- Jun 17, 2024 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Lots: Lot R24B25FA; Exp. 2/28/2026 - Aug 11, 2023 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Lots: a) Lots Y403948, Exp 30-Sep-2024; Lot Y406277, Exp 31-Oct-2024. b) Lot 408790, Exp 30-Nov-2024 and c) Lots Y403740, Y403740A, Exp 30-Sep-2024; Lots Y405638, Y405805, Y407304, Y407304A Exp 31-Oct-2024; Lots Y407717, Y407717A, Y408554, Exp 30-Nov-2024; Lot Y420075, Exp 30-Apr-2025 - Aug 11, 2023 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Lots: Lot Y406734, Exp 31-Oct-2024 - Mar 15, 2023 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Lots: Lot #: a) Y406130, Exp 31-Oct-2024; b) Lots Y406314, Y406314A, Y406963, Y407199, Exp 31-Oct-2024 - Mar 15, 2023 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Lots: Lot Y405201, Exp 31-Oct-2024 - Jan 2, 2019 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Lots: Lot #: Y281477, Expiry: 02/2020 - Aug 7, 2014 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Lots: Lot #: C940700, C940841, Exp 05/16 - 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.
Lots: Lot number: C903799, Exp 05/15 - 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.
Lots: Product Code: L5B4826, Lot #: C886820, Exp 11/14
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride and Dextro: every company that makes it
- Form
- injection, solution, intraperitoneal
- Strength
- 5 ingredients
- Approval
- NDA NDA017512
- On the market since
- Sep 27, 1978
- Package NDCs
0941-0409-010941-0409-050941-0409-060941-0409-07- Official label
- DailyMed (National Library of Medicine), updated Apr 16, 2026
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