Amgen Recalls Anemia Drug Due to Polyester Particles
Amgen is recalling nine lots of its anemia drug Aranesp after a small number of syringes were found to potentially contain cellulose and/or polyester particles.
Amgen initiated the recall last month in several countries outside the U.S. after routine quality testing discovered one or two particles in the syringes, which exceeded the products’ post-release control limits, spokesman Cuyler Mayler said.
Amgen did not receive any complaints or adverse event reports for the lots, which were only distributed to 14 international countries including Sweden, France, Belgium, Saudi Arabia, Kuwait and the UK.
“Aranesp distributed in the U.S. is not impacted by this recall nor is product supply impacted,” the drugmaker said.
The company said that the health risks depend on the size and amount of particles injected into the patient and underlying health conditions. Particulates could create inflammatory or allergic reactions that could be life-threatening.
Medical safety reviews concluded the small numbers of particles observed pose a very low to negligible potential risk to patients, Mayler said.
Aranesp (darbepoetin alfa) is used to treat anemia associated with chronic renal failure.
Avoid a costly recall. Make sure your products are free from particles and other contaminants by purchasing Manufacturing Sterile Products to Meet EU and FDA Guidelines today.