Home / Recalls / Huons Co., Ltd. / D-0531-2026

D-0531-2026 Class II Ongoing

Recalled by Huons Co., Ltd. — Jecheon, N/A

Recall Details

Product Type
Drugs
Report Date
April 22, 2026
Initiation Date
April 2, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,120,750 ampules

Product Description

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 for Recall

Lack of Assurance of Sterility

Distribution Pattern

USA Nationwide.

Code Information

All lots within expiry

Other recalls by Huons Co., Ltd.

  • D-0530-2026 Class II — Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7 (April 2, 2026)
  • D-0529-2026 Class II — Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx (April 2, 2026)
  • D-0532-2026 Class II — Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, (April 2, 2026)