Huons Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0531-2026Class II0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, ManufacApril 2, 2026
D-0530-2026Class IIBupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, RApril 2, 2026
D-0529-2026Class IILidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured April 2, 2026
D-0532-2026Class IILidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, ManufacturApril 2, 2026