Wednesday, March 27, 2013
Another Compounding Pharmacy Recalls All Products After Contaminant Found In Several Drug Compounds Posted: March 27, 2013 Author: Jennifer Walker-Journey
Once again, the Food and Drug Administration (FDA) is ordering therecall of all sterile products manufactured by a compounding pharmacy, this time because visible particles were seen floating in several different compounds. The FDA says the potential health risksare unknown at this point because the contaminant is as yet unidentified. 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 recall was ordered on all sterile products made by Pallimed Solutions, Inc., based in Woodburn, Mass., which does business as Pallimed Pharmacy. The 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 and were distributed to patients and/or physicians’ offices through Friday, March 22, 2013. Patients and doctors who received these products are in 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.
The recall of all sterile products from Pallimed follows within weeks or days of two similar recalls from compounding pharmacies that distribute products across state lines.
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