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Spectra Medical Devices, Llc: Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Kor

DrugsSource: FDA (drug) · Date: 2026-06-10

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Spectra Medical Devices, Llc
Product
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.
Reason / hazard
Lack of Assurance of Sterility
Classification
Class II
Status
Ongoing
Distribution / sold at
USA Nationwide
Recall initiated
2026-05-12
Code info
Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
Product quantity
210625 ampules
Voluntary mandated
Voluntary: Firm initiated
City
Wilmington
State
MA
Country
United States
Event id
98976
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