BETHESDA, MD 22 April 2013—Concerns about the quality control processes at Balanced Solutions Compounding Pharmacy LLC in Lake Mary, Florida, have led to the pharmacy recalling all of its compounded sterile preparations that have not expired, according to an April 17 press release (PDF).
The pharmacy's list (PDF) of products includes such preparations as betamethasone injection, DMSO bladder irrigation solution, and sodium tetradecyl sulfate injection.
FDA inspected the pharmacy in mid-March and found black particles in seven vials of triamcinolone acetonide injectable suspension and a "cloth-like filament" in one vial of chromium chloride injectable solution, according to the investigators' report (PDF).
The investigators reported that the pharmacy had not validated the process for sterilizing the triamcinolone suspension.
Chromium chloride injection does not appear on the list of products being recalled. In the press release, the pharmacy said it had already recalled that product. FDA had identified gram-negative bacteria in a sample of the chromium product, the pharmacy said.
On April 12, Balanced Solutions issued a statement (PDF) acknowledging FDA's inspection and declaring the pharmacy knew of "no patient safety concerns."
However, the pharmacy also stated it had temporarily suspended all sterile compounding, issued a product withdrawal "for all of the products in question," and retrained "associates" on quality compliance.
Balanced Solutions Compounding Pharmacy describes itself as a division of Axium Healthcare Pharmacy Inc.