Official recall notice

FDA DrugClass IINotable

0.9% Sodium Chloride Injection Recall (Apr 2026) – Huons

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.

Recall date
2026-04-22
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

Lack of Assurance of Sterility

One email a week when there are new recalls. Confirm by email; unsubscribe anytime.

Product description

Lack of Assurance of Sterility

Verify with the official notice →
Share:

Related Recalls

2026-04-22 · FDA_DRUG
FDA Recall: Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactur
Huons Co., Ltd.
2026-04-22 · FDA_DRUG
FDA Recall: Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, R
Huons Co., Ltd.
2026-04-22 · FDA_DRUG
FDA Recall: Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured
Huons Co., Ltd.