The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Reason for recall: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. Distribution: US Nationwide distribution. Quantity: 512 kits Lot/code info: 1) CIT6780, UDI-DI: 10653160324232(each), 00653160324235(case), Lot Number: 2025102790; 2) CIT3225A, UDI-DI: 00653160165142(each), 10653160165149(case), Lot Number: 2025102190; 3) CIT6325, UDI-DI: 10653160294160(each), 00653160294163(case), Lot Number: 2025102390
10653160324232, 00653160324235, 00653160165142, 10653160165149, 10653160294160, 00653160294163
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.