The Nation - News from Oct. 8, 1989

The Food and Drug Administration wants a New York pharmaceutical manufacturer to recall an antibiotic used to treat urinary tract infections because it believes the company cheated on product safety tests, an FDA official said. An FDA probe found indications that Bolar Pharmaceutical substituted the brand name product Macrodantin for its generic version of the drug nitrofurantoin in tests to win product approval, said FDA spokesman Jeff Nesbit. “Because of the evidence indicating a substitution, it is not possible for the FDA to assure whether the Bolar product is therapeutically equivalent to the brand name product at this time,” Nesbit said. The Washington Post quoted Bolar President Robert Shulman as saying the company would decide by early this week whether to recall the product. Shulman said there is “no difference” between the drug that was tested and Bolar’s version now on the market.