Monday, March 25, 2013

CBS/AP/ March 25, 2013, 1:05 PM Mass. compounding pharmacy--Pallimed- recalls drugs after surprise investigation

OSTONA Massachusetts pharmacy has issued a voluntary recall of some sterile compounding products following an unannounced inspection by state and federal regulators.
Pallimed Solutions Inc., of Woburn, said Monday the recall was a precautionary measure and there were no reports of any illnesses. The company also said it had agreed to temporarily stop all sterile compounding activities until further notice, but that it would continue with nonsterile compounding.

A person familiar with the investigation told The Associated Press a foreign substance was visible in several vials of a compound during a recent inspection by the state board of pharmacy and U.S. Food and Drug Administration and that the substance was being analyzed to determine what it was. The person spoke on condition of anonymity because the investigation was ongoing.
The company says the recalled products were prepared for fewer than 800 patients and the recall doesn't involve any other product. There are no indication the products were tainted or unsafe, Pallimed added.
Most of the recalled items were used to prepare erectile dysfunction treatments for patients who have difficulty taking drugs orally. The company said fewer than 800 patients were involved.
The state issued a cease-and-desist order covering sterile compounding following the inspection, Pallimed said.
A message left with the FDA was not immediately returned.
Massachusetts stepped up unannounced inspections of compounding pharmacies after a deadly fungal meningitis outbreak last year was linked to an injectable steroid for back and joint pain produced at another Massachusetts company, New England Compounding Center.
That outbreak was responsible for 720 illnesses in 20 states, including 48 deaths, according to the most recent update from the Centers for Disease Control and Prevention (CDC).
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