Huons Co., Ltd. recalls 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra M
Recalled April 22, 2026 · FDA recall D-0531-2026 · Huons
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
7,120,750 ampules
Sold at
USA Nationwide.
Description
Lack of Assurance of Sterility
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.
Manufacturer(s)
Huons Co., Ltd.
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →