Pallimed Recalls All Sterile Compounded Drugs Due to Presence of Particulates in Some Vials

Topics: Compounding and Patient safety

To ensure patient safety, Pallimed Solutions, Inc, of Woburn, MA, has initiated a voluntary recall of all sterile compounded products dispensed since January 1, 2013. Results of a joint inspection conducted by the FDA and the Massachusetts Board of Registration in Pharmacy showed that visible particulates were observed in vials of certain sterile compounded products. The particulate matter has not yet been identified, so the potential health risks are unknown. To date, no injuries or illnesses have been reported. However, particulate matter can cause damage to or obstruct blood vessels, causing various health issues. Thus, the company recalled all sterile products compounded since January 1, 2013, out of an abundance of caution. Recalled products were distributed to patients and physicians offices through March 22, 2013. A full list of the affected products is included in a news release on the FDA Web site. Users of the products should discontinue use. Instructions for returning the products to Pallimed are available on the company’s Web site or by calling 781/937-3344.