Florida-based Balanced Solutions Compounding Pharmacy has issued a voluntary recall of all lots of its sterile non-expired drug products sold nationwide following concerns that their sterility may be compromised and the products may contain bacteria, according to the U.S. Food and Drug Administration (FDA).
The company, headquartered in Lake Mary, Fla., is the compounding pharmacy unit of clinical specialty pharmacy provider Axium Healthcare Pharmacy and licensed to market products in 50 states and provides its production to hospitals and other healthcare providers. The recall has also been posted on the company's website but no information regarding the amount of recalled products has been given. Balanced Solutions stated that it had gladly cooperated with FDA inspectors and had welcomed their help in the case.
Regulators pointed out that so far there has been no record of illnesses or other problems associated with Balanced Solutions' products but warned all healthcare organizations that have received sterile products manufactured by the company, including injectables, to quarantine the products and to follow precisely the company's recall instructions. All patients who have been administered products from the manufacturer have been urged to contact their healthcare provider, the FDA said in a statement.
Balanced Solutions was one of the 30 compounding pharmacies that the FDA investigated between February and April as part of a targeted action by officials to look into sanitary practices and safety standards. The move was triggered following the discovery of major safety lapses at a Massachusetts pharmacy, the New England Compounding Center (NECC), during last year's fungal meningitis outbreak, when 53 people died as a result of tainted steroid shots produced by the NECC. Multiple other safety problems were observed at the monitored compounding pharmacies, highlighting a need for stricter control and more stringent oversight. As a result of the inspections, several compounding pharmacies have announced recalls over the past few weeks.
While FDA inspectors were at the Balanced Solutions facility they recorded poor practices and conditions, which may have led to the company's sterile products being exposed to microbial contamination. These observations raised concerns about a possible lack of sterility assurance, which was later confirmed by the FDA. The analysis of a sampled chromium chloride injection from Balanced Solutions discovered the presence of a type of contaminant, gram-negative bacteria, in the product. Gram-negative bacteria can cause disease and many types of infection, but the Sphingobacterium thalpophilum bacteria isolated in the solution does not usually cause infection in humans, the FDA explained in its statement.
In addition, FDA investigators also found what was described as "black particles of unknown origin" in seven vials of an injectable steroid, which were not identified. At the Balanced Solutions facility 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 Washington Post reported.