Medicine recalls
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| The United States: Recall - Amgen issues voluntary recall of nine lots of Aranesp (darbepoetin alfa) (500 mcg) Prefilled Syringes in several countries outside of the United States due to the presence of visible particulates |
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Amgen initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination. Lots 1042847, 1044141A, 1044141C, 1044141D, 1046891A, 1046891B, 1047394A, 1047622A, and 1047996A are being recalled as a precautionary measure.
In the U.S., Aranesp is indicated for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis or in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. The potentially impacted product is Aranesp 500mcg prefilled syringes which were distributed outside of the United States. The presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life-threatening. To date, there have been no complaints or adverse events reported that can be attributed to the presence of these particles. Evaluations by Amgen found a very low potential to impact patients who may have received the affected product.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm410011.htm
In Hong Kong, there are six registered Aranesp products, namely Aranesp Prefilled Syr Inj 10mcg/0.4ml (HK-51754), Aranesp Prefilled Syr Inj 40mcg/0.4ml (HK-51755), Aranesp Prefilled Syr Inj 20mcg/0.5ml (HK-51756), Aranesp Prefilled Syringe Inj 30mcg/0.3ml (HK-55416), Aranesp Prefilled Syringe Inj 50mcg/0.5ml (HK-55591), and Aranesp Prefilled Syringe Inj 100mcg/0.5ml (HK-55592). All the products are prescription-only medicines registered by Kyowa Hakko Kirin (Hong Kong) Co., Limited (Kyowa). Related news has been released by the UK MHRA, and was posted on the Drug Office website on 2 July 2014. So far, the Department of Health has not received any local adverse drug reaction report related to visible particulates in the products. As confirmed with Kyowa, the affected lots have never been imported into Hong Kong, and the manufacturer of the registered Aranesp products in Hong Kong is different from the one which manufactured the affected lots.
Ends/ Friday, August 15, 2014
Issued at HKT 13:00
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