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Huons Co., Ltd.: 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC,

DrugsSource: FDA (drug) · Date: 2026-04-22

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Huons Co., Ltd.
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.
Reason / hazard
Lack of Assurance of Sterility
Classification
Class II
Status
Ongoing
Distribution / sold at
USA Nationwide.
Recall initiated
2026-04-02
Code info
All lots within expiry
Product quantity
7,120,750 ampules
Voluntary mandated
Voluntary: Firm initiated
City
Jecheon
State
N/A
Country
Korea (the Republic of)
Event id
98724
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