Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.

Recall Number: D-0554-2026

Firm: Spectra Medical Devices, Llc

Classification: Class II

Status: Ongoing

Report Date: 20260610

Initiation Date: 20260512

Termination Date:

Lack of Assurance of Sterility

Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.