Second Company Issues Drug Recall After Sterilization Problems Uncovered
By Emily Mapp Brannon, Medical Malpractice Attorney
A company with the same founders as the specialty pharmacy linked to a deadly fungal meningitis outbreak that has already killed two people in Virginia is recalling all of its products after federal inspectors said it must improve its sterilization 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 said that it issued the recall only “out of an abundance of caution.”
Ameridose makes several 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, including two right here in Virginia.
Ameridose and the NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. According to Ameridose, it is a completely separate entity. However, Cadden, who was the lead pharmacist at NECC, has recently announced his resignation from his role at Ameridose.
The Virginia Personal Injury Lawyer’s Perspective:
As experienced Virginia dangerous drug attorneys, my colleagues and I have helped clients through many cases like this one. Sadly, thousands of people experience the pain of taking a medication prescribed by their doctor only to have it cause serious health problems later on. This happens far too often and the side effects can last a lifetime.
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About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis & Appleton include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Rick Shapiro and James Lewis have been listed among the Best Lawyers in America since 2008. They, along with fellow attorney Randy Appleton, have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of outstanding attorneys receive.