A Florida-based compounding pharmacy is voluntarily recalling all lots of its sterile non-expired drug products sold nationwide over concerns that the products may contain bacteria, federal regulators said Sunday.
The Food and Drug Administration asked hospitals and other health-care providers who received sterile products, including all injectables, from Balanced Solutions Compounding Pharmacy, a division of Axium Healthcare Pharmacy of Lake Mary, Fla., to immediately check their medical supplies, quarantine the products and follow the company’s recall instructions. Patients who were administered any sterile drug products made and distributed by Balanced Solutions should contact their health-care providers.
Officials are not aware of any illnesses, an agency spokesman said. The company, which says it is licensed to operate in all 50 states, posted the recall on its Web site but did not say how many products are affected.
The pharmacy is one of 30 compounding pharmacies — those that custom mix medication for individual patients — that the FDA inspected between February and April, part of a targeted action after inspectors found filthy conditions at the New England Compounding Center, the Massachusetts pharmacy in the middle of last fall’s fungal meningitis outbreak. Tainted steroid shots made by NECC have killed 53 people.
Federal inspectors have found dozens of safety problems at these pharmacies. They focused on firms that make high-risk sterile products, a key segment of the compounding industry. Several compounding pharmacies have issued recalls in the past several weeks.
An FDA inspection of Balanced Solutions found “poor practices and conditions which may have exposed the company’s sterile products to microbial contamination,” the agency said in a statement. Inspectors discovered “black particles of unknown origin” in seven vials of an injectable steroid, according to their report. They also found “a cloth-like filament of unknown origin” in one vial of chromium-chloride injections, an additive used for intravenous nutritional supplements.
The FDA has identified gram-negative bacteria, a type of contaminant, in samples of the chromium chloride, officials said Sunday. Gram-negative bacteria can cause disease and many types of infection. It’s not known what the black particles are, an FDA spokesman said.
Company officials did not immediately return telephone calls Sunday. But in statements posted on it Web site, the firm said it was issuing the recall because of “concerns associated with quality control processes, which present a lack of sterility assurance.” It also said it had welcomed and cooperated with inspectors.