FDA Recall N/A

Huons Co., Ltd. · Jecheon, N/A

Ongoing 42 days on record

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.

Lot / code: All lots within expiry

Quantity: 7,120,750 ampules

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: N/A
Classification: Not Yet Classified
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Nationwide.
Recall initiated: 2026-04-02
FDA published: 2026-04-22
Recalling firm: Huons Co., Ltd.
Firm location: Jecheon, N/A, Korea (the Republic of)

Drug identification

Brand name(s): SODIUM CHLORIDE
Generic name(s): SODIUM CHLORIDE
Manufacturer(s): Spectra Medical Deviecs, LLC
NDC(s): 65282-1505, 65282-1510
Route(s): INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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