Intravenous products: The FDA report “Pallimed Solutions, Inc. of Woburn, MA, doing business as Pallimed Pharmacy, is voluntarily recalling all sterile compound products dispensed since January 1, 2013 to the user level, including all strengths, all dose forms, and all products within expiry date. Recent inspections conducted by the FDA and the Massachusetts Board of Registration in Pharmacy found visible particulates (filaments) observed in vials of several different sterile compounded products. See the Press Release for a listing of all products affected by this recall.
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.”