NDC 0338-0023

Dextrose 100 g per 1000 mL injection, solution

On the label: Baxter Healthcare Corporation.

Where it's 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	Round Lake, IL, United States	Tests it	Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action

Recalls

Jul 6, 2017 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Bags have the potential to leak.
Lots: Lot: P361618, Exp 09/30/18;
Mar 24, 2015 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Lots: Lot #: C963413 and C963413A, Exp 7/31/2016
Mar 24, 2015 · Class I · Baxter Healthcare Corp.
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Lots: Lot #: C965558 and C963520, Exp 7/31/2016
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 #: C926899, Exp 7/31/2015
Nov 21, 2013 · Class I · Baxter Healthcare Corp.
Presence of Paticulate 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 #: P285288, Exp 11/13
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 2B0088: P280115, P285239, Exp 7/13; b) Product code 2B0089: P280230, P280461, P285288, P285288A, P285783, Exp 8/13

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug: Anhydrous Dextrose: every company that makes it
Form: injection, solution, intravenous
Strength: 100 g per 1000 mL
Approval: NDA NDA016694
On the market since: Jan 25, 1971
Package NDCs: 0338-0023-02 0338-0023-03 0338-0023-04
Official label: DailyMed (National Library of Medicine), updated Jun 11, 2026

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