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Publication: European Stars and Stripes Sunday, October 8, 1989

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   European Stars And Stripes (Newspaper) - October 8, 1989, Darmstadt, Hesse                                Page 4 the stars and stripes sunday october 8,1989 Fra asking for recall of Antibiotic Washington a the food and drug administration wants a new York pharmaceutical manufacturer to re Call an Antibiotic used to treat urinary tract infections because it believes that the company cheated on product safety tests an Fra official said saturday. An Fra investigation found indications that Bolar pharmaceutical co. Inc. Substituted the Brand name product for ils own in tests three years ago to win approval of its own generic product Fra spokesman Jeff Nesbit said. Because of the evidence indicating a substitution it is not possible for Fra to assure whether the Bolar product is the Rancu tidally equivalent to the Brand name product at this time he said. Bolar based in Copiague n.y., and the largest of several generic drug makers now under Fra scrutiny won approval for ils generic version of the drug Nitro furan Tom in june 1988. Bolar s product is the Only generic drug currently on the Market that is the Rancu locally equivalent to Macro Amin made by Norwich Eaton pharmaceuticals. The Fra has not asked people taking the generic medication to switch to the Brand name product. And it does thave the authority to remove a product from the Market. If a company docs not comply with an Fra recall request the Agency can Only Force a recall in court. Saturday s Washington Post quoted Bolar president Robert Shulman As saying the company would investigate extenuating circumstances Over the weekend an then decide whether to recall the product. The Fra is also trying to remove from the Market Bolar s version of the popular drug by azide which is for High blood pressure. It questions whether to Lar s product is  equivalent to the Brand name drug and is prob ing whether test samples were switched. The Post quoted unidentified Federal officials As saying Bolar is also under criminal investigation regarding data it submitted to the Fra on its version of Dyaz Ide. In addition the Fra is investigating an other alleged incident of product switching by Bolar involving an anti psychotic drug it was developing in 1982. Bolar officials have said that the incident was a manufacturing error and that the version of Shiori Dazine involved was never marketed. The Fra is investigating More than dozen generic drug companies in the Wake of allegations of fraud and corruption within the Industry and the Fra s generic drug division. Best Sellers quilted memorial to aids victims people gather on a 13-ton quilt that lies unfolded on the Ellipse near the White House on Friday. The quilt memorializing More than 12,000 who have died of aids was making its third and final appearance in the nation s capital. The memorial quilt has 10,848 panels containing the names and some personal items of aids Vic Tims. On saturday about 100 demonstrators staged a noisy die in in front of the White House calling for More Federal help to provide housing for people with acquired immune deficiency syndrome. Thornburgh s use of official aircraft defended by Justice department Washington a the Justice department is defending attorney Gen eral Dick Thornburgh s use of govern ment aircraft for private travel including a trip to a convention in Hawaii aboard a Boeing 727 in which he and five assistants were the Only passengers. David Runkl a spokesman for Thornburgh said the Federal Bureau of investigation has determined that for his personal Security and the Security of his communications he should travel by government  the Fri is a Branch of the Justice department which Thornburgh Heads. Runkl said Thornburgh was sur prised however to learn that the Only government aircraft for the Hawaii trip was a 727, a Large commercial size Jet used by the . Marshals service to Fly prisoners around the country. He thought that it was bizarre when he got inside the plane but the 727 waste Only plane available that could get him there Runkel said. The flight from san Francisco to Honolulu Cost the government $38,000, according to a report saturday in the new York times. The paper said it had exam ined records showing that Thornburgh s 48 trips in the last year Cost taxpayers $191,000. The general accounting office an investigative Arm of Congress is looking into the trips the paper reported. More than a year ago Thornburgh restricted government paid travel by jus Tice department employees to trips directly related to the Job. Conventions such is the trip to Hawaii arc among the pc pc to people Type exchanges that were ruled out. Former attorney general Edwinm Csc 111 had been criticized for his travels including a trip to a Legal symposium with five other department officials in Japan. A Csc usually took commercial flights. Runkl said Thornburgh would not have flown the 727 to Japan except that another plane had broken Down. But a letter from the marshals service also an Arm of the Justice department said the Jet had been requested six weeks before the Hawaii trip the times reported. An unidentified Fri official told the times that the Hawaii leg of the trip Cost $38,000. A first class round trip ticket Between san Francisco and Honolulu costs about $1,400. 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