Pallimed Pharmacy recalled all sterile compounded products dispensed since January 1, 2013. The recall resulted from a recent inspection conducted by the FDA and the Massachusetts Board of Registration in Pharmacy. Inspectors observed visible particulates (filaments) in vials of the following sterile compounded products: TRIMIX, BIMIX (Lot 02252013@3), ALPROSTADIL, DMSO 50 PERCENT – IRRIGATION (Lot 03122013@19), and BACTERIOSTATIC WATER FOR INJECTION (Lot 01072013@28).
The potential public health risks are unknown as the particulate matter has not yet been identified. However, particulate matter has the potential to damage or obstruct blood vessels, which could induce emboli, cause systemic allergic reaction, or cause tissue responses to the foreign material.
The recalled products are used for a wide range of therapeutic uses, including for treatment of erectile dysfunction, testosterone replacement therapy, vitamin injections, and ophthalmic preparations. All products are packaged in glass vials. All products were distributed to patients and/or physicians’ offices through Friday, March 22, 2013, from Woburn, Massachusetts.
Products were distributed directly to patients and/or physicians’ offices located in some or all of the following states: California, Connecticut, Florida, Georgia, Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, Nevada, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, and Wisconsin.
See the Recall