Recall D-0531-2026

US Class II Ongoing · initiated 2026-04-02

Recalling firm

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 for recall

Lack of Assurance of Sterility

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