Tennessee Pharmacy Voluntarily Recalls Sterile Compounded Products, FDA Works With State Regulators in Ongoing Investigation

Food and Drug Administration (FDA) has issued an alert warning against the use of sterile products compounded and dispensed by Main Street Family Pharmacy, LLC, of Newbern, TN. The agency is working with the Centers for Disease Control and Prevention and the Tennessee Board of Pharmacy to investigate the adverse reactions of seven patients who received injections of preservative-free methylprednisolone acetate (MPA) compounded by the pharmacy. FDA indicates that clinical information on these patients’ reactions is still pending, but at least one reaction appeared to be fungal in nature. The Tennessee Department of Health reported that MPA was sent to facilities in Alabama, Arkansas, California, Florida, Kansas, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee, and Texas. Out of an abundance of caution, Main Street Family Pharmacy has voluntarily recalled all sterile products and is cooperating with state and federal authorities in the investigation. A full list of recalled products is available in an FDA press release. The agency has asked that health care providers and patients report any reactions associated with the company’s products to the FDA MedWatch Safety Information and Adverse Event Reporting Program using the online form or by following the instructions on the Web site to submit a report by mail or fax.