NDC 84549-049
Sodium Chloride 9 g per 1000 mL injection, solution
On the label: ProPharma Distribution. It's repackaged: ProPharma Distribution rebottles it from Baxter Healthcare Corporation's NDC 0338-0049.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation | Marion, NC, United States | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionFeb 9, 2024 · 9 inspections, 3 with FDA action |
| 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 |
| Bieffe Medital SA | Sabinanigo (Senegue), Spain | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilyApr 11, 2025 · 4 inspections |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Tests it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
Repackaging site
- ProPharma Distribution, Westminster, CO, United States · repackages it and relabels it
Recalls
- Aug 17, 2026 · Class I · Baxter Healthcare Corporation
Presence of particulate matter: Particulates identified as fiberglass
Lots: Lot: Y495523, Y495523A, Exp 31-Oct-2027 - Jul 18, 2019 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Bags have potential to leak.
Lots: Lot #s: P389684; P389742, Exp. 8/31/2020 - Sep 6, 2018 · Class II · Baxter Healthcare Corporation
cGMP Deviation
Lots: Lot: P380063 Exp. 12/2019 - Aug 21, 2018 · Class II · Baxter Healthcare Corporation
CGMP Deviations
Lots: Lot #: P380287, Exp. date 12/2019 - Jul 6, 2017 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Customer complaints for leaking bags.
Lots: Lot: Y229153, Exp 09/30/18 - Jul 6, 2017 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Bags have the potential to leak.
Lots: Lots: P361501, P361667, and P361790, Exp 09/30/18 - Dec 15, 2015 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Lots: Lot # C980227; Exp. 11/16 - Sep 2, 2015 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
Lots: Lot #: P329821, Exp 08/31/2016 - 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#: P319921, Exp 12/15 - Jul 2, 2015 · Class II · Baxter Healthcare Corp.
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
Lots: Lot #: C964601, Exp 4/30/2016 - Mar 24, 2015 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Lots: Lot #: C965038, C965293, C963785, C963884, C963660, C964320, C964486 and C964890, Exp 7/31/2016 - Mar 23, 2015 · Class II · Baxter Healthcare Corp
Lack of Assurance of Sterility; increased complaints received for leaks
Lots: Product code: 2B1308; Lot#: P316497, exp date: 10/2015 - Mar 18, 2015 · Class II · Baxter Healthcare Corp.
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Lots: Lot #: C929844, Exp 5/31/2015; C926873, Exp 4/30/2015; C928630, Exp 4/30/2015. - Jul 30, 2014 · Class II · Baxter Healthcare Corp.
Lack of Assurance of Sterility; complaints of mold in the overpouch
Lots: Lot #C926642, Product Code: 2B1323N - Jul 11, 2014 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Lots: Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14 - Nov 21, 2013 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Lots: Lot #: a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14 - 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 2B1301: P279943, P280370, Exp 7/13; b) Product code 2B1302: P280248, P280248A, P280248B, P285346, P285791, Exp 8/13; c) Product code 2B1306: P285601, Exp 5/13; d) Product code 2B1307: P280347, Exp 8/13; e) Product code 2B1308: P280404, P280404A, P285635, P285858, Exp 11/13; e…
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, solution, intravenous
- Strength
- 9 g per 1000 mL
- Approval
- NDA NDA016677
- On the market since
- Dec 9, 1970
- Package NDCs
84549-049-48- Official label
- DailyMed (National Library of Medicine), updated Dec 18, 2025
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