Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility: Bags have the potential to leak.
National Drug Code
Is NDC 0338-0017-04 recalled?
Dextrose · 1000 mL in 1 BAG (0338-0017-04)
Yes — this exact package was recalled
1 FDA recall names the code 0338-0017-04 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Dextrose Monohydrate
- Strength
- DEXTROSE MONOHYDRATE 50 g/1000mL
- Form
- Injection, Solution · Intravenous
- Labeler
- Baxter Healthcare Corporation
- Type
- Human Prescription Drug
- Product code
- 0338-0017
Recalls naming this package
Class I · High risk
5% Dextrose Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Class I · High risk
5% Dextrose Injection
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
Class II · Moderate risk
5% Dextrose Injection
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.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
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