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Jan
30
RU-486 Manufacturer Linked To Contaminated Drugs
Filed Under FDA, RU-486, Shanghai Hualian, health, health care, mifepristone
The New York Times is reporting that the Chinese maker of all RU-486 abortion pills distributed in the United States — Shanghai Hualian — is mired in a tainted leukemia drug scandal involving 200 injured cancer patients.
Chinese drug regulators have accused the manufacturer of the tainted drugs of a cover-up and have closed the factory that produced them. In December, China’s Food and Drug Administration said that the Shanghai police had begun a criminal investigation and that two officials, including the head of the plant, had been detained.
The drug maker, Shanghai Hualian, is the sole supplier to the United States of the abortion pill, mifepristone, known as RU-486. It is made at a factory different from the one that produced the tainted cancer drugs, about an hour’s drive away.
The United States Food and Drug Administration declined to answer questions about Shanghai Hualian, because of security concerns stemming from the sometimes violent opposition to abortion. But in a statement, the agency said the RU-486 plant had passed an F.D.A. inspection in May. “F.D.A. is not aware of any evidence to suggest the issue that occurred at the leukemia drug facility is linked in any way with the facility that manufactures the mifepristone,” the statement said.
Expect websites to pop up soon asking if people have been injured by RU-486 aka mifepristone when the trial attorneys get back from the American Association for Justice’s 2008 winter convention in sunny San Juan.
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The usual hype of media headlines. The so-called tainted drugs resulted from the fact two different drugs were stored in one refrigerator in one of the manufacturing plants only and human error was involved which resulted in cross-contamination between those two drugs.
The plant that manufactures mifepristone, only manufactures that 1 drug in that plant so there is no risk of cross-contamination with other drugs. If you have a look at any drug regulators (or other regulators) list of recalls, you’ll find that can human error can result in defective products of all sorts and can happen to any company.
Hi Mary,
Thanks for the update and additional information.