Labeler · US market

Guerbet LLC

Guerbet LLC is a US drug labeler with US FDA registrations covering 4 drug concepts (4 currently active) across 44 packages. It is currently the only active US supplier of 1 drug.

ACTIVE — US

openFDA · updated weekly

Labeler codes67684

Active drugs4

Registrations14 active / 14

Packages44

Sole supplier of1 drugs

Portfolio4 drugs · US

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

Drug	Type	NDCs	Packages	Status
Gadopiclenol injection	rx	9	28	SUPPLYING
Gadoterate Meglumine injection	rx	3	13	SUPPLYING
Ethiodized Oil injection	rx	1	2	SUPPLYING
Ioversol powder	other	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.

Ethiodized Oilrx

At a glance

TypeLabeler
Labeler codes67684
Filing names1
Drugs (active)4
Drugs (all time)4
US registrations14
Packages44

Recent events

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

Sep 13, 2019
RECALLRecall (Class II): Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Sy…
Sep 13, 2019
RECALLRecall (Class III): Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton, …

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; figures cover the entity across all its filing names.