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5 charged with generic drug offenses


A federal grand jury this week charged five former officials of a Brooklyn, N.Y., firm with selling generic drugs that had not been approved by the U.S. Food and Drug Administration.

The six-count indictment in U.S. District Court in Baltimore charged that Jay Marcus, the former president of Halsey Drug Co. Inc., and four other former company executives conspired to obstruct regulation by the FDA.

Company officials allegedly shipped adulterated and unapproved generic drug products interstate in violation of federal law. Other charges include filing false statements with the FDA and obstruction of inspection.

The grand jury charged the officials with changing the ingredients and manufacturing processes of generic drug products without FDA approval. The panel alleged the officials hid documents from the agency.

Federal officials said the drugs affected by the alleged practice were quinidine gluconate, used to treat irregular heartbeats; propylthiouracil for treatment of thyroid problems; metronidazole for serious infections including meningitis; and acetaminophen and codeine phosphate, a narcotic painkiller.

The other defendants are Hedviga Herman, Halsey's former vice president of manufacturing; Frederick Shainfeld, former senior vice president of technical and regulatory affairs; Amirul Islan, former vice president of technical services; and Muhammad Uddin, former assistant vice president of research and development.

Each of the five officials faces a maximum penalty of 10 years in prison and $500,000 in fines.

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