Labeler · US market

Spectra Medical Devices, LLC

Spectra Medical Devices, LLC is a US drug labeler with US FDA registrations covering 3 drug concepts (3 currently active) across 5 packages. It is currently the only active US supplier of 1 drug. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Spectra Medical Deviecs, LLC

ACTIVE — US

openFDA · updated weekly

Labeler codes65282

Active drugs3

Registrations4 active / 4

Packages5

Sole supplier of1 drugs

Portfolio3 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Sodium Chloride injection, solution	rx	2	2	SUPPLYING
Alcohol, Menthol, And Benzocaine Prep Pad swab	otc	1	2	SUPPLYING
Lidocaine Hydrochloride Anhydrous injection, solution	rx	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

Alcohol, Menthol, And Benzocaine Prep Padotc

At a glance

TypeLabeler
Labeler codes65282
Filing names2
Drugs (active)3
Drugs (all time)3
US registrations4
Packages5

Recent events

Shortages, recalls, and registration changes across all filing names.

May 12, 2026
RECALLRecall (Class II): Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmi…
Jun 14, 2018
SHORTAGEDrug shortage: Lidocaine Hydrochloride Injection (Spectra Medical Devices, LLC)

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile (see “Also files as” above); figures cover the entity across all its filing names.