Anemia drugs Procrit and Epogen interact with glass vials over time to produce glass flakes, and that has led to an Amgen recall of the parenteral. The recalled lots were old, and the glass flakes, known as lamellae and described as "extremely thin and barely visible" by an Amgen spokesperson, could lead to blood clots in patients, says Bloomberg.
The California biotech giant makes both drugs at a plant in Puerto Rico, says Reuters. It sells Epogen, most often used for dialysis patients. Johnson & Johnson's Centocor Ortho Biotech unit licenses Procrit, which it distributes mainly for cancer and HIV patients.
The recall affects 324,000 Procrit vials and 200 lots of Epogen.
Amgen has ratcheted back the expiration dates for the drugs to minimize the likelihood of flaking. The former 36-month shelf life has been cut to 12 months and 15 months for single- and multi-dose vials. And the company says it will begin using another vial maker.
The recall is expected to have a minor impact on Amgen because it concerns materials rather than production processes, says a Bernstein analyst in the Reuters report, in contrast to the major upheavals being experienced by Genzyme stemming from production problems for its Cerezyme and Fabrazyme drugs, and by J&J's Tylenol unit from the quality process meltdown concerning Tylenol and siblings.