Earlier this week, Balanced Solutions compounding pharmacy of Lake Mary, Florida announced a voluntary recall of 53 drugs after an FDA inspection found gram-negative bacteria in one of their products. Quality control in compounding pharmacies is crucial to patient safety, as a lack of sterility may put the patient at an increased risk for infection or illness. Just days after the Balanced Solutions recall, the FDA discovered sterility concerns in an Indianapolis-based compounding pharmacy, leading to a multi-state recall.
An FDA inspection of Nora Apothecary & Alternative Therapies revealed that the pharmacy did not appropriately test its products or maintain a sterile environment. As a result, the compounding pharmacy issued a voluntary recall of 95 non-expired drugs that were made on or prior to April 19 and distributed to twelve Indiana medical professionals. Additionally, the recall also includes prescriptions compounded for patients in Illinois, Florida, Ohio and Tennessee.
Charles Lindstrom, pharmacist and owner of Nora Apothecary & Alternative Therapies, has defended his business, proclaiming: “We are and have always been compounding prescription using the highest quality ingredients with the utmost care to ensure the health and safety of our patients.” However, this recall is not the first problem officials have had with Nora. In 2007, the pharmacy’s license faced probation due to prescription distribution issues.
Nora will contact customers to inform them of the recall, and concerned patients who may have been administered a recalled product are advised to contact their health care providers. According to the FDA, the pharmacy has not received any reports of injury or illness linked to the recalled products.
Last year, the New England Compounding Center of Massachusetts distributed more than 17,000 contaminated steroid injections, which led to a deadly meningitis outbreak. As a result, the FDA has been conducting dozens of inspections at compounding pharmacies across the country to ensure that proper quality control and sterilization standards are being observed.