Two Compounding Pharmacies Recall Sterile Products Over Sterility Assurance Concerns
Two pharmacies have voluntarily recalled their sterile compounded products because of concerns associated with quality control processes and a lack of sterility assurance. Balanced Solutions Compounding Pharmacy, LLC, has recalled its sterile, compounded products within their expiration date. A list of the recalled products is included in a news release. In addition, Indiana-based Nora Apothecary & Alternative Therapies has initiated a voluntary, multi-state recall of all compounded sterile drug products. Specifically, the recall includes approximately 95 dosage units of sterile compounded products (PDF) that the pharmacy supplied to the offices of 12 licensed medical professionals located within Indiana. This recall also includes approximately 400 prescriptions compounded for patients in Indiana and prescriptions compounded for patients in four other states: Florida, Illinois, Ohio, and Tennessee. Food and Drug Administration (FDA) urges consumers and health care providers to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program.