A company with the same founders as the specialty pharmacy linked to a deadly fungal meningitis outbreak is recalling all of its products after federal inspectors said it must improve its sterility testing process.
Officials with the FDA have said that a routine inspection turned up inadequate quality assurance related to Ameridose’s sterile products. The FDA was quick to say that it has not discovered any infections linked to the recalled products from Ameridose. In a statement, Ameridose declared it issued the recall “out of an abundance of caution.”
Ameridose makes several injectable drugs which can be used in anesthesia or to correct acid imbalances in the body during critical care. Ameridose agreed to shut down for inspection in October after contaminated steroids from the New England Compounding Center (NECC) were linked to a growing fungal meningitis outbreak.
The FDA warned that six drugs produced by Ameridose were already on the FDA’s list of drugs in short supply. According to the FDA, the Ameridose recall could exacerbate one or more of the shortages of these drugs. Given the shortages, the FDA is working with manufacturers of the six drugs, asking that they ramp up production if they are willing and able to do so.
According to the Centers for Disease Control and Prevention, there have been reports of 386 fungal meningitis cases throughout the country related to the NECC recall. The CDC also announced that there have been 28 deaths in the following states: Florida (3), Indiana (3), Maryland (1), Michigan (7), North Carolina (1), Tennessee (11) and Virginia (2).
Ameridose and the NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. According to Ameridose, it is a separate entity. However, Cadden, who was the lead pharmacist at NECC, has resigned from his role at Ameridose. In a bizarre bit of news, it was recently revealed that despite an internal investigation showing serious contamination problems at the lab, NECC has been sending customers report cards declaring how clean its facilities are.
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Source: “Ameridose recalls all drugs after FDA finds problems with its sterility testing,” by Chelsea Conaboy, published at Boston.com.
