Huons Co., Ltd.: 0.9% Sodium Chloride Injection, Usp
Recall Summary Huons Co., Ltd. is recalling 0.9% Sodium Chloride Injection, USP (a sterile saline solution in 10 mL ampules) distributed nationwide because the company cannot guarantee the product is sterile. This is a Class II recall, meaning use of the product could cause serious adverse health effects. The recall affects the product with NDC number 65282-1510-1 manufactured by Huons Co., Ltd. and distributed by Spectra Medical Devices, LLC.
- 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
- Classification
- Class II
- 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
- USA Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/e5730caf-1918-42cf-95dc-5db8ea561735