Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
National Drug Code
Is NDC 0338-0049-31 recalled?
Sodium Chloride · 16 BAG in 1 PACKAGE (0338-0049-31) / 50 mL in 1 BAG
Yes — this exact package was recalled
4 FDA recalls name the code 0338-0049-31 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.
1 of these recalls is still ongoing.
- Active ingredient
- Sodium Chloride
- Strength
- SODIUM CHLORIDE 9 g/1000mL
- Form
- Injection, Solution · Intravenous
- Labeler
- Baxter Healthcare Corporation
- Type
- Human Prescription Drug
- Product code
- 0338-0049
Recalls naming this package
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: Bags have potential to leak.
Class II · Moderate risk
Class II · Moderate risk
0.9% Sodium Chloride Injection USP 100 mL bags
CGMP Deviations
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: Customer complaints for leaking bags.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
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.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; increased complaints received for leaks
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; complaints of mold in the overpouch
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Class I · High risk
0.9% Sodium Chloride Injection
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
Class II · Moderate risk
Sodium Chloride 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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