Amgen, J&J anemia drugs recalled over glass flakes

The glass flakes result from interaction of drug with glass vials over the shelf life of the product.

New York: Amgen Inc and Johnson & Johnson are recalling their Epogen and Procrit anemia treatments because of the potential for barely visible glass flakes in vials containing the injectable medicines.

The contaminated product has the potential to cause serious problems, including dangerous blood clots, Amgen said in a press release announcing the recall. However, Amgen said there had been no complaints that can be directly attributed to the presence of glass. It said certain lots were being voluntarily recalled as a precaution.
The glass flakes result from the interaction of the drug with glass vials over the shelf life of the product, Amgen said.

Amgen manufactures Epogen and Procrit in the United States, where it sells Epogen and J&J`s Centocor Ortho Biotech unit distributes Procrit. J&J has been dealing with a rash of recalls for its consumer medicines.

Amgen said the recall is being conducted in cooperation with the U.S. Food and Drug Administration.
The drugs have been blockbuster products for the companies, but their sales and those of other anemia drugs, which boost red blood cells, have fallen sharply in recent years because of concerns over potential heart risks from overly high doses.

Amgen shares rose 0.5 percent to $56.02 in early trading. J&J was up 0.5 percent at $62.14.

Bureau Report