0.9% Sodium Chloride Injection recall (Huons Co., Ltd.)
DrugClass IIOngoing
Summary: Huons Co., Ltd. is recalling 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.
What is being recalled
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.
Why
Lack of Assurance of Sterility
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
USA Nationwide.
How to tell if yours is affected
All lots within expiry
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0531-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 2, 2026 |
| Reported | April 22, 2026 |
| Company | Huons Co., Ltd. |
| Company location | Jecheon, N/A, Korea (the Republic of) |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7,120,750 ampules |
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