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Amid indications that more people may have died or been harmed after being given a brand of the blood thinner heparin, federal drug regulators said Thursday that they had found “potential deficiencies” at a Chinese plant that supplied much of the active ingredient for the drug.
Baxter International, which makes the brand of heparin associated with the problems, and buys supplies from the Chinese plant, announced that it was expanding a recall to include virtually all its heparin products.
The Food and Drug Administration said the number of deaths possibly associated with the drug, made from pig intestines, had risen to 21 from 4.
The Chinese heparin market has been in turmoil over the last year, as pig disease has swept through the country, depleting stocks, leading some farmers to sell sick pigs into the market and forcing heparin producers to scramble for new sources of raw material.
Scientific Protein Laboratories, a Wisconsin company that is the majority owner of the Chinese plant, issued a statement Thursday saying the F.D.A.’s finding did not represent its final determination as to whether the plant complied with federal regulatory rules. S.P.L., the statement said, is committed to finding the root cause of the adverse reactions.