BETHESDA, MD 28 Nov 2012—Bracco Diagnostics Inc. on Tuesday announced a recall of nine lots of Isovue iopamidol injection in power injector syringes because of visible particles in the cardiovascular imaging agent.
The company said the particles have the potential to harm patients. To date, the particles have been found only in syringes the company had retained for stability studies.
This recall, which the company said is Class I, affects Isovue-370 lots 9L40746, 0A43705, 0C57509, 9K37791, 0C57521, and 0E62913 and Isovue-300 lots 9K34572, 0A43282, and 0C56283.
Syringes in those lots entered the supply chain from January 21, 2010, through May 9, 2012, the company said.
Hospitals, other health care facilities, and health care providers are being directed by the company to immediately quarantine all syringes from the nine lots and contact Stericycle, at 866-201-9133 8 a.m. to 5 p.m. EST Monday through Friday, to arrange for return of the product.
FDA defines a Class I recall as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
Bracco said its iopamidol product is for use in angiography of the cardiovascular system, including cerebral arteries.
None of the National Drug Code sequences listed by Bracco in its press release appear in the federal National Drug Code Directory dated November 26.