Class II
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.
Lack of Assurance of Sterility
- Recall number
- D-0531-2026
- Report date
- April 22, 2026
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- Huons Co., Ltd.
- Generic names
- SODIUM CHLORIDE
- Brand names
- SODIUM CHLORIDE
- Product NDCs
- 65282-1505, 65282-1510
Code and lot information
All lots within expiry
Distribution
USA Nationwide.
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.