Ameridose Products Recalled Due to Safety Concerns
Drug maker Ameridose, which shares the same management team as the New England Compounding Center, issued a recall of all of its unexpired products in circulation. The epidural steroid injections manufactured by the NECC have been linked to the nationwide fungal meningitis outbreak that has killed almost 30 people. While there have not been any reports of infections associated with Ameridose products, the FDA reports that this recall has been issued out of an abundance of caution.
The State of Massachusetts and the FDA have been conducting an investigation into the practices at both the NECC and Ameridose since early October. The preliminary findings at the NECC production facility cited the presence of dirt and other pathogens throughout the lab as well as a lack of sterilization procedures for the medications that it produced. The FDA stated that the current investigation of the Ameridose facility has raised concerns about a lack of sterility assurance for products manufactured there.
Compounding facilities such as the NECC and Ameridose are regulated by the state board of pharmacy where the company resides. The FDA has limited authority over facilities like these as they are not classified as drug manufacturers but rather specialized pharmacies that fill custom prescriptions for a patient per a doctor’s order. However, as the investigation continues into the practices at NECC, records have shown large quantities of drugs have been manufactured at this facility which would indicate that it was operating more like a drug manufacturer rather than a compounding pharmacy.
At this time, there have been no reports of illness or infection from patients who received Ameridose products. However, any patient who has an adverse event related to an Ameridose product should seek immediate medical attention.
Lawsuits have been filed against NECC by patients who received a contaminated epidural steroid injection and contracted fungal meningitis. Six Indiana facilities received these products manufactured by NECC. Forty eight Hoosiers have contracted fungal meningitis and three have died. If you or someone you care about had an epidural steroid injection and has experienced symptoms of fungal meningitis such as severe headache, stiff neck, dizziness, vomiting, and light sensitivity seek immediate medical attention. Contact us and speak with one of our personal injury attorneys who are available to speak with you regarding your legal rights and options.