Not Yet Classified

Drug Recall: 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,

Huons Co., Ltd. · April 2, 2026

Reason for Recall

Lack of Assurance of Sterility

Product Description

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.

Distribution

Nationwide.

States Affected

NATIONWIDE

Quantity Affected

7,120,750 ampules

Source: FDA (openFDA Drug Enforcement)

Recall number: N/A

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.