Berlex, Inc. initiated the nationwide recall of a single lot (No. 41500A) of its intravenous X-ray contrast agent, Ultravist® Injection 370 mgI/mL, 125 mL (iopromide injection) NDC 50419-246-12, EXP 01/2007 because of the presence of particulate matter in conjunction with crystallization.
Ultravist® is a nonionic, iodinated, low osmolar radiological contrast agent for intravascular administration that has been introduced in Europe in 1985 and in the in 1995 and is being used today in over 100 countries worldwide.
The presence of the particulate matter has the potential for serious safety problems in the case that the product is administered to patients which includes thrombosis of blood vessels, thromboembolism, and injury or infarction of end organs such as heart, kidney, and brain.
Berlex has been working closely with the ISFDA in communicating and coordinating this recall and urging hospitals, imaging centers and other healthcare facilities not to use any of the affected lot number 41500A of Ultravist® Injection 370mgI/mL, 125 mL for patient care and should immediately quarantine any product for return and to contact Berlex at 1-866-BERLEX-5 or 1-866-237-5395.
Berlex, Inc. is a affiliate of Schering AG,
More details at the Berlex press release.
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