July 14, 2022

FDA Allows US Providers to Buy Bayer Foreign-Labeled Contrast Media

Due to iodinated contrast media shortages caused by a temporary shutdown of a GE Healthcare plant in Shanghai, the U.S. Food and Drug Administration (FDA) will now allow Bayer® to import a limited quantity of foreign-labeled ULTRAVIST® (iopromide).

Per Bayer’s “Dear Healthcare Provider” communication, this imported stock is manufactured at the same site as ULTRAVIST (iopromide) intended for the U.S. market; but is not labeled with current FDA-approved labeling.

Providers are directed to the full U.S. Prescribing Information (USPI) for ULTRAVIST (iopromide) to ensure the USPI are followed. Get more details from Bayer and the FDA.

For more information, contact Gloria Romanelli, American College of Radiology® (ACR®) Senior Director, Legislative and Regulatory Relations and Legal Counsel, Quality and Safety.

The ACR also encourages members to visit the ACR Contrast Media Shortage Page.