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美國兩家原料藥生產商產品受污染宣布召回
發布時間: 2013-09-08     來源: 生物谷

    兩家原料藥生產廠家Wellness Pharmacy 公司和JCB Laboratories公司由于旗下產品收到微生物污染的原因而宣布召回6批產品。不久之前德克薩斯州有17名患者由于使用了受到污染的產品而加重病情。目前已經有2名患者死亡,但死因尚在調查中。有鑒于此,FDA在全美范圍對原料藥廠家展開安全調查。
詳細英文報道:
    Two more compounding pharmacies are voluntarily recalling products as FDA inspectors roll through the plants of the largest of those drugmakers and tag them for problems. These recalls are tied to problems inspectors found with the microbial contamination testing done by a testing lab used by both: Front Range Laboratories of Loveland, CO. The Birmingham, AL-based Wellness Pharmacy and JCB Laboratories of Wichita, KS, both recalled 6 lots of products. Earlier this month, Specialty Compounding of Cedar Park, TX, recalled all of its sterile drugs after 17 patients in Texas developed blood infections after getting infusions of calcium gluconate manufactured by the compounder. Texas authorities said two of the patients died but the cause of their death was still be determined.

 

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