Yet another drug compounding company that holds a license to sell its products in Tennessee is recalling all of its sterile injectable drugs after federal inspectors found evidence of bacterial contamination in one of its products.
The recall announced Sunday by the U.S. Food and Drug Administration is being conducted by Balanced Solutions Compounding of Lake Mary, Fla. Among the products being recalled are vials of methylprednisolone acetate, the same spinal steroid blamed for a nationwide fungal meningitis outbreak that has killed 15 Tennessee residents and sickened more than 150.
Tennessee Health Department records show Balanced Solutions, a division of Axium Healthcare Pharmacy, has been licensed in Tennessee since Aug. 19, 2011, and its license will expire Aug. 31 of this year. Axium also holds a Tennessee pharmacy license, which expires July 31.
According to the FDA, its inspectors discovered "poor practices and conditions" during a recent inspection at the company, and subsequent testing turned up evidence of a gram negative bacteria in an injectable drug, chromium chloride, produced by the company.
"The FDA's preliminary findings of sterile production practices and conditions at the site raise concerns about a lack of sterility," the FDA said in announcing the recall.
However, the FDA reported that the exact type of bacteria discovered, Sphingobacterium thalpophilum, does not usually cause infection in humans.
The drug is generally prescribed as a supplement to patients undergoing intravenous feeding.
The recall comes as the FDA is continuing a stepped-up inspection and enforcement effort on compounding drug firms following the nationwide fungal meningitis outbreak caused by a Massachusetts drug compounder, New England Compounding Center.
The latest Tennessee death in the outbreak came Tuesday when 71-year-old Carol Wetton of Guthrie, Ky., died at the Saint Thomas Hospital in Nashville.
According to the Florida company, a total of 53 different sterile drug products are being recalled. The FDA advised health care providers and facilities with sterile products from the company to quarantine them immediately. Patients using Balanced Solutions products are advised to contact their health care providers.