Actavis Totowa, LLC, the maker of defective Digitek tablets, now faces a lawsuit filed by the U.S. Justice Department that seeks to shut down substandard manufacturing plants in New Jersey.
In April 2008, Actavis Totowa recalled Digitek tablets because some of the medication contained twice the active ingredient normally found in Digitek. According to the Food & Drug Administration (FDA), the Digitek defect could cause serious and even fatal reactions in users. The FDA deemed the Digitek recall a Class I recall, its most serious recall.
In August, Actavis issued another recall of all generic drugs made at its Little Falls, N.J. facility. The recall was prompted by an inspection at the facility which revealed that operations did not meet the FDA’s standards for good manufacturing practices. The Little Falls factory also produced some of the faulty Digitek recalled earlier.
According the Justice Department lawsuit, the FDA conducted five inspections of three Actavis facilities in Totowa and Little Falls, New Jersey over the last three years. Despite written warnings to the company, during its last inspection this year, the FDA continued to find numerous and recurring violations of Good Manufacturing Practice requirements. The FDA also found that the company continued to manufacturer and distribute unapproved new drug products, the complaint says.
The complaint also states that during its most recent inspection this year, the FDA found that Actavis Totowa’s failure to comply with the Good Manufacturing Practice requirements resulted in, among other things, the company’s release of the defective Digitek tablets
According to a Department of Justice press release, Actavis recently informed that FDA that they would like to restart manufacturing drug products at the New Jersey facilities. However, the Justice Department said that Actavis has not demonstrated to the FDA that it can do this in compliance with the Good Manufacturing Practice requirements.
The lawsuit seeks a permanent injunction to bar Actavis Totowa and Actavis Inc, as well as two of their officers, from the manufacturing and distribution of generic drug products until they demonstrate compliance with the Good Manufacturing Practice requirements of the Federal Food, Drug and Cosmetic Act.
“FDA and the Justice Department are committed to ensuring that drugs sold in the United States are safe and effective,” Gregory Katsas, Assistant Attorney General for the Justice Department’s Civil Division, said in the press release. “As part of this commitment, we have and will continue to file injunction actions to enforce strict compliance with Good Manufacturing Practice requirements.”
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