Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: identified as cardboard.
National Drug Code
Is NDC 0338-0553-18 recalled?
Sodium Chloride · 100 mL in 1 BAG (0338-0553-18)
Yes — this exact package was recalled
6 FDA recalls name the code 0338-0553-18 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
- Sodium Chloride
- Strength
- SODIUM CHLORIDE 900 mg/100mL
- Form
- Injection · Intravenous
- Labeler
- Baxter Healthcare Corporation
- Type
- Human Prescription Drug
- Product code
- 0338-0553
Recalls naming this package
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Class I · High risk
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Class I · High risk
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Class II · Moderate risk
0.9% 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.
Class II · Moderate risk
0.9% Sodium Chloride Injection
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.
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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