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‘Foreign Matter’ Prompts Another Compounding Pharmacy Recall

Update Date: Mar 25, 2013 09:43 PM EDT
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The FDA approved Northera to treat neurogenic orthostatic hypotension. (Photo : REUTERS/Jason Reed)

A Massachusetts pharmacy issued a voluntary recall Monday has recalled more than a dozen products it made and distributed since Jan. 1, after regulators found "foreign matter" in vials of injectable drugs.

Pallimed Solutions Inc., of Woburn, was also ordered by the state board of pharmacy to stop all sterile compounding activities until further notice. The recalled products are used for erectile dysfunction, in hormone replacement therapy, and in eye treatments.

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"The company took this aggressive precautionary recall measure on the basis of information observed during the course of an inspection conducted by the Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy," Pallimed said in a press release on its website. The recall is limited to sterile compounded products dispensed on or after January 1.

"Until further notice, Pallimed will not dispense any sterile compound products and will not engage in any sterile compounding activities," 

The Globe reported in December that the state had ordered Pallimed to stop producing one drug, sildenafil citrate, known by brand name Viagra, because the product was being made with "improper components."

This is the second compounding pharmacy to be investigated in less than two weeks for unsafe conditions. And only a matter of months since over 700 people were made sick and 50 patients died after receiving injections of medications produced at the New England Compounding Center.

The LA Times reports, "The absence of strong FDA enforcement powers over compounding pharmacies, and the discovery of filthy conditions at the New England Compounding Center, has spurred more aggressive FDA efforts to monitor conditions at compounding pharmacies, which repackage existing prescription into made-to-order medications."

Massachusetts ramped up inspections of compounding pharmacies after a deadly fungal meningitis outbreak was linked to a steroid produced at another company, New England Compounding Center in Framingham.

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