Huons Co., Ltd.: 0.9% Sodium Chloride Injection, Usp
Recall Summary Huons Co., Ltd. is recalling 0.9% Sodium Chloride Injection (saline solution) in 10 mL ampules distributed nationwide because the company cannot guarantee the product is sterile. This injectable medication was manufactured for Spectra Medical Devices and distributed across all U.S. states and Washington, D.C. The affected product is identified by NDC number 65282-1510-1.
- 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
- Lack of Assurance of Sterility
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-02
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/777b9470-3a14-4005-9159-f8bdfff81299