Recall: D-0531-2026

Class II - Potentially Harmful

Class IIClassification

2026-04-02Initiated

OngoingStatus

Huons Co., Ltd.Firm

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

Lack of Assurance of Sterility

Distribution

USA Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.