Regulators report that Ameridose also failed to investigate potentially serious side effects reported with drugs. One complaint involving the company's painkiller fentanyl states the "patient was over-sedated, unresponsive." A complaint for oxytocin, which is used to induce labor in pregnant women, states that the "patient had shortness of breath, the throat was closing, and coughing."
Ameridose said in a statement Monday that it will work to address the issues cited by FDA. But it stressed that "Ameridose's history shows clearly that we have not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product."
Ameridose and NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. Ameridose says it is a separate entity with distinct management. Since the outbreak, Cadden, the lead pharmacist at NECC, resigned his post as director at Ameridose. He is scheduled to testify before Congress at a hearing Wednesday examining the outbreak.
Last week Ameridose laid off nearly all of its 650 employees and 140 employees at its marketing and support arm, Medical Sales Management, due to the company's extended shutdown.