FDAFDA · Food and drugs·Recall number D-0531-2026
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.
Published April 22, 2026 · Recall initiated: April 2, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated
Recall details
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Huons Co., Ltd.
- Distributor
- USA Nationwide.
- Lot
- All lots within expiry
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Korea (the Republic of)
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