Class II · Moderate risk
Heparin Sodium and 0.9% Sodium Chloride Injection
Subpotent Drug; out of specification results for heparin raw material
National Drug Code
Is NDC 0338-0431-03 recalled?
Heparin Sodium in Sodium Chloride · 18 BAG in 1 CARTON (0338-0431-03) / 500 mL in 1 BAG
Yes — this exact package was recalled
3 FDA recalls name the code 0338-0431-03 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
- Heparin Sodium
- Strength
- HEPARIN SODIUM 200 [USP'U]/100mL
- Form
- Injection, Solution · Intravenous
- Labeler
- Baxter Healthcare Corporation
- Type
- Human Prescription Drug
- Product code
- 0338-0431
Recalls naming this package
Class II · Moderate risk
Heparin Sodium in 0.9% Sodium Chloride Injection
Subpotent Drug: Heparin raw material was found to have low potency
Class II · Moderate risk
Heparin Sodium and 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.
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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