NDC 0338-0553
Sodium Chloride 900 mg per 100 mL injection
On the label: Baxter Healthcare Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation | Jayuya, PR, United States | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilyJul 19, 2024 · 15 inspections, 5 with FDA action |
| Baxter Healthcare Corporation | Aibonito, PR, United States | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilySep 23, 2026 · 4 inspections |
| Baxter Healthcare Corporation | Marion, NC, United States | Tests it | Serious problems, FDA actionFeb 9, 2024 · 9 inspections, 3 with FDA action |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Tests it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
Recalls
- Jan 21, 2016 · Class II · Baxter Healthcare Corp.
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Lots: Lot #: P337857, Exp 07/31/16 - Jan 21, 2016 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: identified as cardboard.
Lots: Lot #: P328997, Exp 01/31/2016 - Jul 17, 2015 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Lots: Lot#: P327635, Exp 12/15 - Dec 4, 2014 · Class I · Baxter Healthcare Corp
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Lots: Lot #: P317891, P317842, Exp 05/15 - Jul 11, 2014 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Lots: Lot #: P308650, Exp 10/14 - May 21, 2013 · Class II · Baxter Healthcare Corp.
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Lots: Lot #: a) Product code 2B0042: P285668, P285668A, P285668C, P285734, Exp 5/13; b) Product code 2B0043: P285395, Exp 5/13 - Feb 27, 2013 · Class II · Baxter Healthcare Corp.
Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
Lots: Lot: P293118; Exp Date: 10/13
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 Cation: every company that makes it
- Form
- injection, intravenous
- Strength
- 900 mg per 100 mL
- Approval
- NDA NDA020178
- On the market since
- Dec 7, 1992
- Package NDCs
0338-0553-110338-0553-18- Official label
- DailyMed (National Library of Medicine), updated Jan 27, 2020
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