Amgen is voluntarily recalling 9 lots of an anemia drug from 14 countries outside of the U.S. after syringes were found to have cellulose and polyester particles in them. The recall comes at a tough time for Amgen's ($AMGN) manufacturing operations, which were just targeted for big cuts as part of CEO Robert Bradway's effort to prepare the company for future competition to a key product.
The Thousand Oaks, CA-based biotech said that a single lot of 500-mcg prefilled syringes of Aranesp was repackaged into 9 lots that were then shipped to Belgium, Denmark, Finland, France, Ireland, Italy, Kuwait, Luxemburg, Russia, Saudi Arabia, Slovenia, Sweden, Switzerland and the U.K. In a call Tuesday, company officials said that 15,880 syringes were included in the retrieval, MarketWatch reports.
The company issued the alert after a small number of the prefilled syringes were found to be contaminated with particles of cellulose, polyester, or both that were discovered during routine testing. It didn't say if it had discovered the source of the contamination.
Amgen said the risk of adverse reactions is small and none have yet been reported, but it said that if the particles were injected, they could cause an allergic reaction or potentially be fatal. Aranesp is used to treat anemia in patients with chronic renal failure, including those on dialysis, as well as some patients with nonmyeloid malignancies who are receiving chemotherapy. It said problems would vary depending on the route of administration, size of the particles, the medical condition of the patients and "the presence of a right-to-left cardiac shunt."
The recall comes at a difficult time for the company's manufacturing operations. Amgen announced in July that it will cut 12% to 15% of its workforce of 20,000, and roughly 15% to 20% of those cuts will be made in its manufacturing operations. It also said it will close or sell facilities in Washington and Colorado. About 50 manufacturing jobs in Washington state and 430 in Colorado will be lost, most by next year. The cuts are part of an effort to prepare for biosimilar competition to Amgen's top seller, arthritis drug Enbrel.
- here's the recall announcement
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