FDAHealthApril 2, 2026
Huons Co., Ltd. — 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
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 2, 2026
USA Nationwide.
What's affected?
- Product
- 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.
- Brand
- SODIUM CHLORIDE
- Lot code
- within
Additional details
All lots within expiry
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7,120,750 ampules.
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