ST LOUIS (MD Consult) - ETHEX Corporation has expanded 2 previous 2008 recalls to include over 60 generic drug products recalled to wholesalers, and 2 generic drug products, hydromorphone HCl and metoprolol succinate, recalled to retailer level.
These generic products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Some of these products have had specific lots recalled earlier because of defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to make sure no other defective products remain in the marketplace.
Patients who may possess these medicines should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or health care provider if they have experienced any problems that may be related to using these products, or to obtain replacement medications or prescriptions.
Read the complete MedWatch 2009 safety summary, including a list of all the recalled products, links to the firm's press release, and 2 previous alerts, at the following address:
www.fda.gov/oc/po/firmrecalls/ethex01_09.html.
圣路易斯(MD Consult)——ETHEX公司日前对其在2008年颁布的2个召回令的内容进行了增补,共计向批发商召回60余种非专利药,并向零售商召回2种非专利药——盐酸二氢吗啡酮和琥珀酸美托洛尔。
这些非专利药品可能是在不完全符合现有药品生产质量管理规范(GMP)的条件下生产的。由于发现存在缺陷,包括片剂的实际含量高于标注含量,某些产品的某些特殊批次已经在此前被召回。此次召回更多产品,旨在保证市场上没有其他有缺陷产品。
买了这些药物的患者应继续按处方单使用,原因在于突然停用必需药物可能会带来危险。如果出现可能与使用上述产品相关的任何问题,或者为寻求替代药物或其他治疗方法,患者都应与其经治医师或医护人员取得联系。
可以登陆下列网址获得完整版MedWatch 2009安全概述,内容包括所有召回产品目录以及此前的2个召回令:www.fda.gov/oc/po/firmrecalls/ethex01_09.html
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