United StatesLidocaine HCl Injection USP, 25×5 mL single‑dose ampules (NDC 65282-1605-1) distributed by Spectra Medical Devices, LLC, made in South Korea, lot AE4013 (exp 1/31/2027), AE5032 and AE5039 (exp 3/31/2028), and AE5104 (exp 8/31/2028), 210,625 ampules sold nationwide in the U.S., is affected. The product was recalled because of lack of assurance of sterility.
What's being recalled
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.
Recalling firm: Spectra Medical Devices, Llc, Wilmington, MA, United States.
How to identify it
Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
The hazard
Lack of Assurance of Sterility
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
USA Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)