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Bracco Diagnostics recalls angiography drug over particulates

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Another injectable drug is being recalled after particles were seen in the finished product.

Bracco Diagnostics ($BDI) says it is voluntarily recalling 9 lots of Isovue, which are used in Stellant prefilled power injector syringes. It said there have been no reports of adverse events, but BDI pointed out that Isovue is often injected arterially for cerebral angiography and the particles could cause strokes. The injectors were shipped to wholesalers and distributors nationwide from Jan. 21, 2010, through May 9, 2012, the company said. BDI is the U.S. operation for Milan, Italy-based Bracco Group.

Bracco ran afoul of the FDA with this product in 2010 when the agency sent it a letter saying that its packaging material underplayed the product's risks, while its website oversold its benefits. The FDA said Bracco claimed that the drug was better than a competitor's when the study it cited clearly showed that it was not superior.

There have been a number of issues with injectable drug recalls this year. Hospira ($HSP) in the last 8 months has had to recall a number of injectable drugs, some because syringes had been overfilled and some because particulates were found in the drugs. In the latter, it blamed its glass supplier for the problem. With huge investments, the company has been making steady progress at upgrading its plants and is returning to the market some drugs that have been in short supply.

- here's the FDA recall notice
- read the 2010 FDA marketing warning (pdf)

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Hospira blames supplier's bad vials for latest recall