Sodium Chloride Injection, Solution
FDA Recall NDC 65282-1505
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sodium Chloride (NDC 65282-1505). A significant event, classified as Class II, was initiated on Apr 02, 2026 by Spectra Medical Deviecs, Llc. The reported reason for this action was: "Lack of Assurance of Sterility"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility
Apr 02, 2026
Apr 22, 2026
7,120,750 ampules
Recall Profile & Regulatory Data
Event ID
98724
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Huons Co., Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide.
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.
Batch or Lot Expiration Information
Lot# All lots within expiry
Affected Packages Involved in this Recall
65282-1510-1Product
65282-1505-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
