Lipiodol Ultra-Fluide

Generic name:ethiodized oil
Dosage form: injection
Drug class:Iodinated contrast media

Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.

Dear Healthcare Professional,

Due to recent manufacturing issues we would like to inform you of a critical shortage of LIPIODOL ® (ETHIODIZED OIL) INJECTION . Guerbet is coordinating with the FDA to increase the availability of the LIPIODOL ® (ETHIODIZED OIL) INJECTION for US patients.

During this interim period, Guerbet, in conjunction with the FDA, is initiating a temporary importation of LIPIODOL ® ULTRA-FLUIDE , ethyl esters of iodized fatty acids of poppy seed oil, to the United States market. LIPIODOL ® ULTRA-FLUIDE contains the same drug components as LIPIODOL ® (ETHIODIZED OIL) INJECTION (manufactured by Jubliant HollisterStier, Canada). LIPIODOL ® ULTRA-FLUIDE is manufactured in compliance with European Good Manufacturing Practice (GMP) regulations by Delpharm Tours (France) for Guerbet. Delpharm Tours’s manufacturing facility is FDA inspected. The FDA has not approved this product in the United States.

At this time, no other entity except Guerbet is authorized by the FDA to import or distribute LIPIODOL ® ULTRA-FLUIDE . Any sales of LIPIODOL ® ULTRAFLUIDE ampoules from any entity other than Guerbet will be considered in violation of the Federal Food, Drug and Cosmetic Act and may be subject to enforcement action by the FDA.

Effective immediately, Guerbet will offer the following version:

LIPIODOL ® ULTRA-FLUIDE formulation is the same as LIPIODOL (Ethiodized Oil) Injection ®.

The active substance of LIPIODOL ® ULTRA-FLUIDE and LIPIODOL (ETHIODIZED OIL) INJECTION is the same (ethyl esters of iodized fatty acids of poppy seed oil, stabilized with 1% of poppy seed oil).

The barcode used on LIPIODOL ® ULTRA-FLUIDE is an international pharmaceutical manufacturing code and will likely not be recognized by scanning systems used in the United States. Institutions should confirm that barcode systems do not provide incorrect information when the product is scanned. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients.

For questions regarding LIPIODOL ® ULTRA-FLUIDE in th