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FDA announced in a safety alert that Pallimed Solutions, Woburn, Mass., has voluntarily recalled all sterile compounded products dispensed since the beginning of this year because of visible particulates observed in several different vials of its products. Both FDA and the Massachusetts Board of Registration in Pharmacy observed the filaments during inspections.
While the public health risks are not known because the particulate matter has not been identified, the FDA MedWatch communication stated that the particulates have the potential to damage or obstruct blood vessels, and could possibly cause allergic reaction, including tissue responses.
Pallimed Solutions, doing business as Pallimed Pharmacy, had a wide range of products, including those for erectile dysfunction, testosterone replacement therapy, vitamin injections, and ophthalmic preparations. Distribution of products to patients and/or physicians occurred from January 1, 2013 to March 22, 2013.
All products from Pallimed should be returned to the company. To contact the company, visit www.pallimed.com or call 781-937-3344, Monday through Friday (10 a.m. – 5 p.m. EDT).
To report adverse reactions to these products, complete and submit the report online at www.fda.gov/MedWatch/report.htm. The form can also be downloaded or requested at 800-332-1088 and submitted by fax to 800-FDA-0128.