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January 01, 2021

Drugmaker accused of unsafe manufacturing

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Federal prosecutors accuse a California-based company of making animal drugs in unsafe conditions and failing to investigate adverse events.

In a complaint filed Oct. 27, 2020, Department of Justice attorneys sought a shutdown of drug manufacturing, distribution, and related activities by Med-Pharmex Inc. and company officers Gerald P. Macedo and Vinay M. Rangnekar.

A complaint filed in the U.S. District Court for the Central District of California contains accusations that the company’s leaders failed to investigate causes for the death of one horse that received Med-Pharmex–manufactured ivermectin paste and illnesses of 30 pigs that had been administered Med-Pharmex–manufactured iron dextran, as well as failed to investigate a complaint that the company sold ivermectin paste without dosage markings on the syringe. Citing findings from multiple Food and Drug Administration inspections, prosecutors also accused the company of failing to clean and disinfect drug production sites and equipment, including a nozzle used to fill drug vials, as well as numerous failures to maintain sterility, check the quality of products, investigate unexplained particulates in products, and maintain production records.