Japan Scrambles to Recall SPL-made Heparin
This article was originally published in PharmAsia News
TOKYO - Under the guidance of Japan's Ministry of Health, Labor and Welfare, Fuso Pharmaceutical Industries, Otsuka Pharmaceutical and Terumo Corp. work to replace their heparin sodium products that contain active ingredients from Scientific Protein Laboratories
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Japan's Ministry of Health, Labor and Welfare announced that Osaka-based Fuso Pharmaceutical, Tokyo-based Terumo Corp. and Tokushima-based Otsuka Pharmaceutical have begun recalling 17 heparin products. American drug maker Baxter Healthcare's heparin has been linked to severe side effects, including 21 deaths. The three Japanese companies use the same active ingredient for heparin as Baxter, which is imported from American company Scientific Protein Laboratories and made from materials in China. In Japan, 70 percent to 80 percent of the 270,000 dialysis patients use heparin, and Fuso and Otsuka products combined account for 50 percent of the heparin market. (Click here for more - Japanese language
U.S FDA has discovered "significant quantities" of a heparin-like contaminant in tested samples of heparin API manufactured by Baxter-supplier Scientific Protein Laboratories' Changzhou plant
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