New 21-State Recall of Compounded Ophthalmic Solutions
Pallimed Pharmacy is third compounder to recall all products in last 2 weeks.
Published: March 27, 2013
The third compounding pharmacy voluntary recall of all sterile products is upon us. This time, the FDA has issued a safety alert after visible filamentous particulates were observed in "vials of several different sterile compounded products" from Pallimed Solutions, which does business as Pallimed Pharmacy.
The Woburn, Mass., compounder is voluntarily recalling all sterile compound products dispensed between Jan. 1 and March 22, including all strengths, all dose forms and all products within expiry date. 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. Ophthalmic solutions covered by the recall include acetylcysteine ophthalmic solution, cyclosporine ophthalmic, tacrolimus ophthalmic and vancomycin ophthalmic, among other products, according to a company statement.
The recall is the result of recent inspections conducted by the FDA and the Massachusetts Board of Registration in Pharmacy, which has stepped up oversight in the wake of the fungal meningitis outbreak associated with Mass.-based New England Compounding Center. At this time, 5 affected vials have been discovered, but no injuries or illnesses have been reported.
Last week, a New Jersey compounder and a Georgia compounding pharmacy both initiated voluntary recalls of all their sterile compounded products. The FDA has since asked Congress for expanded oversight powers for compounding pharmacies.
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