Reported Apr 22, 2026 · Ongoing
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra…
Huons Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Huons Co., Ltd. · 100 Bio-Valley-Ro · Jecheon, N/A · N/A
Is this the product you have?
- 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free
- Manufactured forSpectra Medical Devices, LLC, Wilmington, MA, 01887
- ByHouns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1
- Lot codes and dates
- All lots within expiry
- Amount recalled
- 7,120,750 ampules
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
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